OUR QUALITY STANDARDS AND TESTING POLICY

Effective Date: April 17, 2026
Last Updated: July 20, 2026

Alpine Aminos supplies materials exclusively for qualified in vitro laboratory research and analytical applications.

Our quality program is designed to create multiple checkpoints throughout sourcing, independent analytical testing, documentation review, batch release, storage, and fulfillment.

Testing is not only about confirming the characteristics we expect. It is also about identifying unexpected issues before they become widespread and adding preventive checkpoints throughout a changing supply chain.

No analytical testing program can detect every possible substance, eliminate every potential risk, or establish suitability for human or veterinary use.

All Alpine Aminos products are sold strictly for Research Use Only.

1. Our Role

Alpine Aminos is a Research Use Only supplier and reseller. We are not the manufacturer of the materials we offer.

Our role may include:

  • Evaluating sourcing relationships;
  • Coordinating independent third-party analytical testing;
  • Reviewing available batch-specific documentation;
  • Applying internal release criteria;
  • Publishing available Certificates of Analysis and laboratory reports;
  • Maintaining product, batch, testing, and fulfillment records;
  • Requesting clarification or additional testing when appropriate;
  • Placing inventory on hold when further review is needed;
  • Declining or rejecting material that does not satisfy our release requirements; and
  • Communicating clearly about what analytical results do and do not establish.

Alpine Aminos is not:

  • A pharmaceutical manufacturer;
  • A compounding pharmacy;
  • An outsourcing facility;
  • A retail pharmacy;
  • A healthcare provider;
  • A medical practice;
  • A veterinary provider;
  • A clinical laboratory; or
  • A supplier of materials intended for human or veterinary use.

2. Independent Third-Party Analytical Testing

Applicable batches are evaluated through independent third-party analytical testing.

Testing may be performed by more than one laboratory. The laboratory, analytical method, instrument, sample-preparation procedure, reporting format, specification, and acceptance criteria may vary depending on:

  • The product;
  • The batch;
  • The analytical objective;
  • The laboratory performing the analysis;
  • Available equipment and methods;
  • Sample quantity;
  • Testing availability; and
  • Alpine Aminos’ release requirements.

Not every laboratory uses the same method for every analytical question.

The applicable Certificate of Analysis or laboratory report should be reviewed to determine:

  • Which laboratory performed the test;
  • Which method was used;
  • Which sample or batch was evaluated;
  • Which specifications or reporting thresholds applied;
  • What result was reported; and
  • What limitations apply to that result.

Use of an independent laboratory does not mean that the laboratory endorses:

  • Alpine Aminos;
  • The product;
  • The Site;
  • A purchaser’s research;
  • Any particular research application; or
  • Human or veterinary use.

3. Six Quality Checkpoints

Alpine Aminos’ current analytical review program may include six separate quality checkpoints for applicable peptide batches:

  1. Identity confirmation;
  2. Purity analysis;
  3. Net content verification;
  4. Endotoxin analysis;
  5. Microbial screening; and
  6. Heavy-metal screening.

Each checkpoint addresses a different analytical question.

A result from one test should not automatically be interpreted as answering questions addressed by another test. For example:

  • Purity does not establish identity;
  • Identity does not establish net content;
  • Net content does not establish microbial status;
  • Microbial screening does not establish endotoxin status;
  • Endotoxin testing does not establish heavy-metal status; and
  • Heavy-metal screening does not establish overall purity.

The specific testing panel may vary by product or batch. Researchers should review the documentation associated with the applicable batch rather than assuming that every product received an identical panel or method.

4. Identity Confirmation

Identity testing is used to evaluate whether the tested sample is consistent with the expected compound.

Depending on the testing laboratory, product, batch, and analytical objective, identity evaluation may include:

  • Liquid chromatography–mass spectrometry, commonly referred to as LC-MS;
  • Qualitative or comparative HPLC analysis;
  • Retention-time comparison;
  • Comparison with a reference standard;
  • Molecular-mass evaluation;
  • Chromatographic-profile review;
  • Spectral or instrumental comparison; or
  • Another appropriate laboratory method identified in the applicable report.

LC-MS Identity Evaluation

LC-MS combines chromatographic separation with mass-spectrometry analysis.

Depending on the method and reporting format, LC-MS may provide information concerning:

  • Observed molecular mass;
  • Mass-to-charge ratio;
  • Expected ion patterns;
  • Chromatographic retention;
  • Presence of a signal consistent with the expected compound; and
  • Other characteristics identified by the laboratory.

An LC-MS result may support confirmation that the tested sample is consistent with the expected molecular identity.

It does not, by itself, establish:

  • Absolute purity;
  • Exact net content;
  • Absence of every impurity;
  • Absence of microorganisms;
  • Endotoxin status;
  • Heavy-metal status; or
  • Suitability for a particular research purpose.

HPLC Identity Evaluation

HPLC is commonly used for chromatographic separation and purity analysis. Under some laboratory procedures, HPLC may also support identity evaluation.

Qualitative or comparative HPLC identity evaluation may use:

  • Retention-time comparison;
  • Comparison with a qualified or laboratory-selected reference standard;
  • Co-injection or related comparative analysis;
  • Chromatographic behavior;
  • Detector response;
  • Peak-profile comparison; or
  • Another laboratory-defined procedure.

HPLC identity language should be interpreted according to the laboratory’s stated method.

A matching or consistent retention time can support identity, particularly when compared with an appropriate reference standard. However, retention time alone may not provide the same molecular information as mass spectrometry.

Method Flexibility

LC-MS and HPLC answer overlapping but different analytical questions. They should not be described as interchangeable unless the applicable laboratory documentation supports that conclusion.

A batch may receive:

  • LC-MS identity confirmation;
  • HPLC-based identity evaluation;
  • Both LC-MS and HPLC;
  • Identity evaluation incorporated into a broader analytical procedure; or
  • Another scientifically appropriate identity method.

Alpine Aminos will describe the identity method according to the applicable laboratory report rather than representing that every batch receives the same identity test.

Researchers should review the applicable documentation to determine:

  • Which identity method was performed;
  • Whether a reference standard was used;
  • Whether identity and purity were evaluated separately;
  • What acceptance criterion applied;
  • Whether the result was qualitative or quantitative; and
  • What limitations the laboratory reported.

An identity result applies to the tested sample under the laboratory’s stated conditions.

Identity confirmation does not independently establish:

  • Absolute purity;
  • Exact total vial content;
  • Absence of every possible contaminant;
  • Sterility;
  • Absence of endotoxin;
  • Absence of heavy metals;
  • Suitability for a purchaser-specific protocol;
  • Regulatory approval; or
  • Safety or suitability for human or veterinary use.

5. Purity Analysis

Purity analysis evaluates the relative amount of the primary detected chromatographic component compared with other detected components under the stated method conditions.

Purity is commonly evaluated using HPLC, although the laboratory may use another chromatographic method where appropriate.

A reported purity percentage should be interpreted according to:

  • The method used;
  • The column and mobile phase;
  • The detector;
  • Wavelength or detection settings;
  • Sample preparation;
  • Peak integration;
  • Laboratory calculation procedures;
  • Reporting conventions;
  • Reference materials, where applicable;
  • The substances detectable through the method; and
  • The laboratory’s stated limitations.

A reported chromatographic purity value generally represents the relative area of the principal detected peak compared with other integrated peaks under the stated method.

It does not necessarily represent the percentage of the complete vial mass consisting of the expected compound.

For example, a chromatographic purity result does not automatically account for:

  • Water;
  • Moisture;
  • Counterions;
  • Residual solvents;
  • Salts;
  • Excipients;
  • Undetected compounds;
  • Nonchromophoric substances;
  • Elements or metals;
  • Microorganisms;
  • Endotoxins; or
  • Materials not measured by the stated method.

A high reported purity result does not establish:

  • Correct identity;
  • Correct net content;
  • Absence of every contaminant;
  • Sterility;
  • Endotoxin compliance;
  • Heavy-metal compliance;
  • Uniformity between every vial; or
  • Suitability for human or veterinary use.

6. Net Content Verification

Net content testing estimates the quantity of the identified analyte present in the tested sample.

Net content is a separate analytical question from purity.

A product may report high chromatographic purity while containing more or less analyte than the nominal label amount. This is why Alpine Aminos treats net content verification as a separate quality checkpoint.

Depending on the laboratory and method, net content analysis may involve:

  • Quantitative chromatographic analysis;
  • Comparison with a reference standard;
  • Calibration curves;
  • Instrument-response calculations;
  • Sample-weight or volume measurements;
  • Moisture or related corrections;
  • Replicate analysis; or
  • Another laboratory-defined quantitative method.

Reported content may be affected by:

  • Sample preparation;
  • Reference-standard accuracy;
  • Calibration;
  • Instrument performance;
  • Measurement uncertainty;
  • Method tolerance;
  • Moisture or counterion assumptions;
  • Sample variation;
  • Laboratory calculation procedures; and
  • Reporting conventions.

A net content result generally applies to the tested sample.

It does not guarantee:

  • Identical content in every vial;
  • Absolute accuracy without uncertainty;
  • Overall purity;
  • Absence of contaminants;
  • Sterility;
  • Suitability for a particular research protocol; or
  • Suitability for human or veterinary use.

The nominal label amount is a product designation. The applicable laboratory report should be reviewed for the reported measured content and any stated tolerance or uncertainty.

7. Endotoxin Analysis

Endotoxin testing evaluates the tested sample for bacterial endotoxin under the laboratory’s stated method and acceptance criteria.

Testing may use a Limulus amebocyte lysate method or another appropriate laboratory procedure.

The applicable report may express results using units such as:

  • Endotoxin units per milligram;
  • Endotoxin units per milliliter;
  • A pass or fail determination;
  • A result below a stated threshold; or
  • Another laboratory-specific reporting format.

A passing endotoxin result generally means that the tested sample met the stated specification under the reported method conditions.

It does not mean:

  • Absolute zero endotoxin was proven;
  • Every vial was individually tested;
  • The product is sterile;
  • No microorganisms are present;
  • The product has been approved for administration;
  • The product is suitable for clinical use; or
  • The product is safe or suitable for human or veterinary use.

Endotoxin testing and microbial screening answer different questions.

A sample may meet an endotoxin specification without establishing absence of viable microorganisms. Similarly, a microbial-screening result does not automatically establish endotoxin status.

Researchers should review:

  • The method;
  • Sample preparation;
  • Reporting units;
  • Detection or reporting threshold;
  • Acceptance criterion;
  • Dilution information;
  • Interference controls, where reported; and
  • The laboratory’s interpretation.

8. Microbial Screening

Microbial screening evaluates the tested sample for evidence of microbial growth or contamination under the laboratory’s stated screening method and observation conditions.

Alpine Aminos uses the term microbial screening unless the applicable report specifically documents a recognized compendial sterility method such as USP <71>.

Microbial screening may vary by laboratory and may involve differences in:

  • Sample quantity;
  • Growth media;
  • Incubation temperature;
  • Incubation period;
  • Culture conditions;
  • Observation schedule;
  • Organisms detectable through the procedure;
  • Positive or negative controls;
  • Acceptance criteria; and
  • Reporting language.

A laboratory may report a microbial-screening result as:

  • No growth;
  • Negative;
  • Pass;
  • No observable growth;
  • Below a stated microbial limit; or
  • Another method-specific result.

These terms must be interpreted according to the laboratory’s procedure.

A “no growth,” “negative,” or “pass” result does not necessarily mean:

  • Absolute absence of every microorganism was proven;
  • Every vial in the batch was tested;
  • The method was USP <71>;
  • The product is sterile for medical or pharmaceutical purposes;
  • Endotoxin is absent;
  • The product is approved for administration; or
  • The product is suitable for human or veterinary use.

Microbial Screening Versus USP <71>

Microbial screening and USP <71> sterility testing should not automatically be treated as equivalent.

USP <71> is a specific compendial sterility-testing framework with defined requirements concerning matters such as:

  • Test method;
  • Sample quantity;
  • Growth media;
  • Incubation conditions;
  • Incubation duration;
  • Method suitability; and
  • Interpretation.

Alpine Aminos will not describe a result as USP <71> unless the applicable laboratory documentation supports that statement.

Where the laboratory performs a noncompendial microbial screen, Alpine Aminos will describe it as microbial screening, microbial growth screening, or similar method-appropriate language.

9. Heavy-Metal Screening

Heavy-metal screening evaluates selected elemental impurities in the tested sample.

The applicable panel may include:

  • Arsenic;
  • Cadmium;
  • Lead; and
  • Mercury.

Depending on the product, laboratory, sourcing considerations, or analytical objective, additional elements may also be evaluated, including:

  • Palladium;
  • Nickel;
  • Chromium;
  • Copper;
  • Cobalt;
  • Platinum; or
  • Other selected elements.

The actual panel should be determined from the applicable laboratory report.

Testing may use:

  • Inductively coupled plasma mass spectrometry, commonly referred to as ICP-MS;
  • Inductively coupled plasma optical emission spectrometry;
  • Atomic absorption spectroscopy; or
  • Another appropriate elemental-analysis method.

A heavy-metal result may be reported as:

  • A measured concentration;
  • Below a reporting limit;
  • Below a quantitation limit;
  • Not detected;
  • Negative;
  • Pass; or
  • Another laboratory-specific result.

These terms apply only to:

  • The elements included in the test panel;
  • The tested sample;
  • The method used;
  • The laboratory’s reporting limits;
  • The stated unit of measurement; and
  • The applicable acceptance criteria.

“Not detected” does not necessarily mean absolute zero was proven. It generally means the element was not measured at or above the method’s stated detection or reporting threshold.

A passing heavy-metal screen does not establish:

  • Absence of every metal;
  • Absence of every possible contaminant;
  • Overall purity;
  • Correct identity;
  • Correct net content;
  • Sterility;
  • Endotoxin status; or
  • Suitability for human or veterinary use.

10. Additional Testing

The six quality checkpoints described above represent Alpine Aminos’ current general analytical review framework for applicable peptide batches.

Additional testing may be performed where appropriate.

Additional analyses may include:

  • Broader elemental screening;
  • Residual-solvent analysis;
  • Water or moisture analysis;
  • Counterion analysis;
  • pH or appearance evaluation;
  • Additional identity confirmation;
  • Repeat purity or content analysis;
  • Microbial enumeration;
  • Method-specific investigation;
  • Confirmatory testing at a second laboratory; or
  • Another test appropriate to a particular concern.

The presence of additional testing on one batch does not mean that every batch requires or receives the same additional panel.

Likewise, the absence of a particular test from a report does not mean that the analyte was evaluated and found absent.

Only tests expressly identified in the applicable documentation should be treated as having been performed.

11. Sampling and Batch Representation

Analytical testing is generally performed on one or more samples associated with an identified batch.

Testing a sample does not mean that every individual vial or unit was separately tested.

Batch-level testing relies on sampling. No sampling plan can establish that every unit is perfectly identical.

Potential sources of unit-to-unit variation may include:

  • Filling variation;
  • Lyophilization variation;
  • Moisture differences;
  • Packaging variation;
  • Storage exposure;
  • Sampling variation;
  • Measurement uncertainty; and
  • Other manufacturing or handling factors.

Alpine Aminos may test more than one sample or vial when appropriate, but this should not be interpreted as every unit testing.

Researchers remain responsible for establishing incoming inspection, sampling, qualification, and testing procedures appropriate to their own research environment.

12. Laboratory Methods and Method Limitations

Analytical results must be interpreted in the context of the method used.

Every method has limitations.

These may involve:

  • Detection limits;
  • Quantitation limits;
  • Specificity;
  • Selectivity;
  • Interference;
  • Sample preparation;
  • Reference-standard quality;
  • Instrument calibration;
  • Analyst technique;
  • Measurement uncertainty;
  • Reporting conventions;
  • Matrix effects;
  • Sample stability;
  • Method suitability; and
  • Laboratory-defined acceptance criteria.

A method may be appropriate for answering one analytical question but not another.

Alpine Aminos does not represent that every laboratory method is:

  • Pharmacopeial;
  • Compendial;
  • FDA-approved;
  • Fully validated for every possible matrix;
  • Suitable for every purchaser’s regulatory needs; or
  • Interchangeable with another laboratory’s method.

Terms such as “validated,” “verified,” “qualified,” “compendial,” or “reference method” should be used only when supported by the applicable laboratory documentation.

13. Laboratory Variation and Repeat Testing

Different laboratories may report somewhat different results when testing samples from the same batch.

Variation may result from differences in:

  • Analytical methods;
  • Instruments;
  • Columns;
  • Detectors;
  • Reference standards;
  • Sample preparation;
  • Calibration;
  • Integration;
  • Reporting thresholds;
  • Acceptance criteria;
  • Analyst procedures;
  • Sample condition; and
  • Measurement uncertainty.

A difference between laboratory results does not automatically prove that one result is incorrect.

When results differ, Alpine Aminos may consider:

  • The methods used;
  • The samples tested;
  • The timing of testing;
  • Sample storage and handling;
  • Laboratory documentation;
  • Reported uncertainty;
  • Method suitability;
  • Reference-standard information;
  • Replicate results; and
  • Other relevant evidence.

Alpine Aminos may request repeat testing or testing by another laboratory when clarification is appropriate.

A retest does not automatically invalidate the original result. Both results may remain relevant to the investigation.

14. Certificates of Analysis and Laboratory Reports

Available Certificates of Analysis and laboratory reports are published to provide batch-specific analytical transparency.

Researchers should match each document to:

  • Product name;
  • Batch or lot number;
  • Sample identifier;
  • Test date;
  • Report date;
  • Laboratory;
  • Analytical method; and
  • Reported result.

A Certificate of Analysis generally reflects findings for the tested sample or identified batch under the laboratory’s stated methods and conditions.

A Certificate of Analysis does not guarantee:

  • Identical results from every vial;
  • Suitability for every research protocol;
  • Satisfaction of every institutional specification;
  • Absence of every possible impurity;
  • Absence of every possible microorganism;
  • Absence of every possible metal;
  • Regulatory approval;
  • Clinical suitability;
  • Pharmaceutical suitability; or
  • Safety or suitability for human or veterinary use.

Researchers are responsible for reviewing the full report rather than relying only on a summary, badge, product-page statement, or headline result.

15. Understanding Common Reporting Terms

Analytical terminology must be interpreted according to the applicable method and report.

Pass

“Pass” generally means the tested sample met a stated laboratory or Alpine Aminos acceptance criterion for the applicable test.

A pass does not mean that every possible quality characteristic was evaluated.

Fail

“Fail” generally means the tested sample did not meet the stated acceptance criterion for the applicable test.

A failing result may lead to:

  • A batch hold;
  • Additional review;
  • Repeat testing;
  • Supplier inquiry;
  • Rejection;
  • Withdrawal; or
  • Another corrective action.

Negative

“Negative” generally means the target was not reported as present according to the method and reporting criteria.

It does not necessarily mean absolute absence.

Not Detected

“Not detected” generally means the analyte was not measured at or above the method’s detection or reporting threshold.

It does not necessarily mean absolute zero.

Below Reporting Limit

“Below reporting limit” generally means the reported amount was below the laboratory’s defined threshold for reliable reporting.

No Growth

“No growth” generally means no observable microbial growth was reported under the stated test conditions and observation period.

It does not prove absolute sterility.

Conforms or Consistent With

“Conforms,” “consistent with,” or similar identity language generally means the tested sample produced results consistent with the expected material under the stated method.

The exact meaning depends on the laboratory procedure.

16. Internal Release Review

Before an applicable batch is released for sale, Alpine Aminos reviews the available analytical documentation against internal release criteria.

The review may consider:

  • Identity results;
  • Purity results;
  • Net content;
  • Endotoxin results;
  • Microbial-screening results;
  • Heavy-metal results;
  • Batch identification;
  • Report consistency;
  • Laboratory comments;
  • Packaging and labeling;
  • Supplier information;
  • Prior batch history;
  • Unresolved discrepancies; and
  • Other relevant quality information.

Possible review outcomes include:

  • Release;
  • Hold pending clarification;
  • Additional testing;
  • Repeat testing;
  • Documentation correction;
  • Supplier inquiry;
  • Rejection;
  • Withdrawal from sale; or
  • Another appropriate action.

A release decision is an internal distribution decision.

It is not:

  • FDA approval;
  • Regulatory approval;
  • Certification for human use;
  • Certification for veterinary use;
  • Pharmaceutical approval;
  • Clinical approval;
  • Medical approval; or
  • A guarantee of suitability for every research application.

17. Batch Holds and Investigations

Alpine Aminos may place a product or batch on hold when:

  • A result is unexpected;
  • A result does not meet release criteria;
  • Documentation is incomplete;
  • A report contains an inconsistency;
  • A laboratory issues a correction;
  • A supplier raises a concern;
  • A packaging or labeling issue is discovered;
  • New information becomes available;
  • A customer reports a potentially relevant issue; or
  • Further review is otherwise appropriate.

During a hold, Alpine Aminos may:

  • Suspend fulfillment;
  • Quarantine remaining inventory;
  • Review retained records;
  • Request laboratory clarification;
  • Submit additional samples;
  • Use another testing laboratory;
  • Review supplier documentation;
  • Contact affected customers;
  • Request preservation of products;
  • Correct or replace documentation;
  • Reject the batch; or
  • Release the batch after the concern is resolved.

A hold or investigation does not automatically establish that a product is defective or unsafe.

It reflects Alpine Aminos’ preventive approach to resolving incomplete, unexpected, or conflicting information before continuing distribution.

18. Product Withdrawals and Customer Notices

If Alpine Aminos determines that a released product or batch should be withdrawn, Alpine Aminos may:

  • Stop further fulfillment;
  • Contact affected customers;
  • Provide batch or product identification;
  • Request that remaining material be segregated;
  • Request preservation of containers and labels;
  • Provide return or disposal instructions;
  • Arrange replacement, credit, or refund where appropriate;
  • Publish an update; or
  • Take another reasonable action.

Customers are responsible for maintaining sufficient order and batch records to identify products in their possession.

The remedy associated with a withdrawal will depend on:

  • The nature of the concern;
  • Available evidence;
  • Applicable law;
  • Product availability;
  • Order records; and
  • The instructions included in the notice.

19. Documentation Corrections and Updates

Analytical documents may occasionally require correction or clarification because of:

  • Typographical errors;
  • Batch-number errors;
  • Sample-identifier errors;
  • Unit corrections;
  • Reporting-format changes;
  • Laboratory amendments;
  • Revised calculations;
  • Additional test results;
  • Updated interpretations; or
  • Other new information.

Alpine Aminos may:

  • Replace a document;
  • Add an amended report;
  • Publish a clarification;
  • Correct a product-page summary;
  • Notify affected customers; or
  • Preserve both the original and corrected records.

A corrected document should be interpreted according to the amendment or replacement issued by the laboratory or Alpine Aminos.

20. Researcher Responsibilities

Alpine Aminos’ quality program does not replace a researcher’s own quality system.

Researchers remain responsible for:

  • Reviewing available batch documentation;
  • Confirming that the report matches the product and batch received;
  • Evaluating method suitability;
  • Determining whether the testing meets institutional requirements;
  • Conducting additional incoming testing where appropriate;
  • Maintaining receiving records;
  • Inspecting products upon delivery;
  • Establishing suitable storage conditions;
  • Restricting access;
  • Preventing contamination;
  • Using qualified personnel;
  • Maintaining laboratory controls;
  • Documenting research;
  • Complying with applicable laws and institutional requirements; and
  • Disposing of materials appropriately.

Researchers should not assume that Alpine Aminos’ release criteria are identical to their own internal specifications.

21. Storage and Handling

After delivery, the purchaser is responsible for appropriate receipt, storage, handling, security, and documentation.

Researchers should:

  • Retrieve shipments promptly;
  • Inspect packaging and labeling;
  • Record the batch or lot number;
  • Review available documentation;
  • Restrict access to authorized personnel;
  • Follow appropriate laboratory procedures;
  • Protect materials from contamination or unauthorized use;
  • Maintain appropriate inventory controls; and
  • Follow lawful disposal procedures.

Alpine Aminos does not provide universal storage or handling instructions for every research environment.

Researchers are responsible for determining appropriate conditions based on:

  • The material;
  • Available documentation;
  • Laboratory procedures;
  • Institutional standards; and
  • The intended lawful research.

22. Research Use Only Restrictions

All Alpine Aminos products are sold strictly for lawful in vitro laboratory research and analytical applications.

Products are not intended for and must not be used for:

  • Human consumption;
  • Human administration;
  • Injection;
  • Ingestion;
  • Inhalation;
  • Topical personal use;
  • Veterinary or animal administration;
  • Clinical use;
  • Therapeutic use;
  • Diagnostic use;
  • Disease prevention;
  • Disease treatment;
  • Disease mitigation;
  • Compounding;
  • Food use;
  • Dietary-supplement use;
  • Cosmetic use;
  • Household use;
  • Self-experimentation;
  • Resale;
  • Redistribution;
  • Relabeling;
  • Repackaging; or
  • Diversion.

Products have not been evaluated or approved by the United States Food and Drug Administration or another regulatory authority for human, veterinary, medical, clinical, diagnostic, or therapeutic use.

Analytical testing does not change the Research Use Only status of a product.

A product does not become suitable for human or veterinary use because it:

  • Reports high purity;
  • Passes identity testing;
  • Meets a net-content specification;
  • Passes endotoxin testing;
  • Reports no microbial growth;
  • Passes heavy-metal screening; or
  • Has an available Certificate of Analysis.

23. No Medical or Veterinary Conclusions

Testing results must not be interpreted as evidence of:

  • Safety in humans;
  • Safety in animals;
  • Efficacy;
  • Therapeutic effect;
  • Appropriate dosage;
  • Appropriate route of administration;
  • Clinical quality;
  • Pharmaceutical quality;
  • Compounding suitability;
  • Diagnostic suitability; or
  • Regulatory approval.

Alpine Aminos does not provide:

  • Dosing instructions;
  • Administration instructions;
  • Treatment guidance;
  • Medical recommendations;
  • Veterinary recommendations;
  • Compounding instructions;
  • Personal-use advice; or
  • Individualized research conclusions.

24. No Absolute Quality Claims

Alpine Aminos avoids absolute claims that cannot be supported by the applicable testing.

Unless expressly supported by a specific report and carefully qualified, Alpine Aminos does not represent that a product is:

  • Free from all contaminants;
  • Free from all heavy metals;
  • Completely sterile;
  • Absolutely pure;
  • Pharmaceutical grade;
  • Medical grade;
  • Clinical grade;
  • FDA approved;
  • Safe;
  • Risk free;
  • Tested for every possible impurity; or
  • Individually tested vial by vial.

Quality statements should be tied to:

  • The applicable batch;
  • The specific test;
  • The method used;
  • The result reported;
  • The laboratory’s threshold; and
  • The limitations of the analysis.

25. Policy Relationship

This Quality Standards and Testing Policy should be read together with:

  • The Terms of Use and Conditions of Sale;
  • The Privacy Policy;
  • The Refund, Cancellation, Replacement, and Claims Policy;
  • The Shipping and Delivery Policy;
  • Product-specific documentation;
  • Applicable Certificates of Analysis; and
  • Required Research Use Only attestations.

If this policy conflicts with the Terms of Use and Conditions of Sale, the Terms control unless this policy expressly provides more specific information concerning analytical testing or quality review.

26. Questions About Testing or Documentation

Questions concerning testing, analytical terminology, Certificates of Analysis, batch documentation, or this policy may be submitted to:

Alpine Aminos LLC
Email: info@alpineaminos.com
Website: AlpineAminos.com

Include the following when available:

  • Product name;
  • Batch or lot number;
  • Order number;
  • Laboratory report;
  • Specific test or result in question; and
  • A clear description of the requested clarification.

Do not include personal medical information, dosing questions, administration questions, or information concerning human or veterinary use.