OSMORAResearch

Osmora Research · Public Batch Release Record

Osmora GH 15 mg

Current lotIPA-26-001

Release decisionPASSReleasedLive release state from Osmora QMS
Core Release Standard9/9 PASS
Extended framework0/7 documented
Release dateSeptember 21, 2026
AvailabilityAvailable for purchase

Release decision logic

Why PASS means more than 9/9.

The nine Core Release Checks are the analytical foundation of the release decision. Osmora's QMS does not permit final QA approval from a 9/9 result alone: documentation, traceability, exception controls and a completed QA Review are also part of the gate.

For this lot:9/9 core checks are PASS and the public disposition isPASS. Extended-framework checks remain tracked separately and do not independently change the displayed Core Release Standard result.

Core release dimensionIdentity & composition

Confirms the named material, purity result and vial-content result against the defined lot criteria.

3/3 PASS
Core release dimensionBiological contaminants

Evaluates the documented endotoxin and PCR microbial-screening results against their release criteria.

2/2 PASS
Core release dimensionElemental impurities

Evaluates the documented elemental-impurity result against the lot-release criterion.

1/1 PASS
Core release dimensionTargeted adulterant screen

Tracks the targeted fentanyl-screening result as a required core release check.

1/1 PASS
Core release dimensionPhysical characterization

Confirms the recorded pH and documented appearance meet the defined lot criteria.

2/2 PASS
QMS release-gate snapshot9 public gate conditions · extended framework excluded from the core gate
✓
Nine core release checks configuredRequirement satisfied
✓
All nine core release checks PASSRequirement satisfied
✓
Original reports attached for core resultsRequirement satisfied
✓
Supplier-document requirement satisfiedRequirement satisfied
✓
Batch identity and supplier lot completeRequirement satisfied
✓
Laboratory assigned to every core checkRequirement satisfied
✓
No unresolved FAIL on core checksRequirement satisfied
✓
No HOLD or blocking quality eventRequirement satisfied
✓
Completed QA Review recordedRequirement satisfied
Gate blockedNot releasable

If a required gate condition is not satisfied, QA approval is unavailable. A failed gate condition does not automatically become a rejection.

HOLDReview paused

An authorized hold requires a recorded reason and prevents approval. Removing a hold returns the batch to QA Review for re-evaluation.

REJECTTerminal disposition

Rejection is a separate authorized Quality Manager action with a required reason. The rejected batch record is preserved.

PASS / RELEASEDFinal QA approval

Approval can be issued only after the gate passes; the QMS re-evaluates the full gate server-side immediately before recording QA approval.

Release is an Osmora analytical/documentation disposition for Research Use Only material. It is not approval for human or veterinary use and does not establish clinical safety or efficacy.

Core Release Standard

Why this lot cleared the release gate.

Checks 01–09 form Osmora's lot-release standard. The primary view shows the measured result, status and evidence path. Method, laboratory, accession, acceptance specification and accreditation/scope context remain available under Technical details.

9 / 9 Core Release Checks PASSFreedom Diagnostics
01
Identity ConfirmationIdentity & Composition
ResultOsmora GH — Confirmed
PASS
View evidence
Technical details
Acceptance specificationIdentity confirmed as Osmora GH
Confirmed methodLC-MS
LaboratoryFreedom Diagnostics
Accession / document ID2609119096
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.
02
HPLC / UPLC PurityIdentity & Composition
Result99.54%
PASS
View evidence
Technical details
Acceptance specification≥99.0%
Confirmed methodHPLC-UV
LaboratoryFreedom Diagnostics
Accession / document ID2609119096
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.
03
Vial Content / Quantity AssayIdentity & Composition
Result14.05
PASS
View evidence
Technical details
Acceptance specificationNot pre-registered
Confirmed methodNot recorded
LaboratoryFreedom Diagnostics
Accession / document ID2609119096
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.
04
Bacterial EndotoxinBiological Contaminants
ResultPass
PASS
View evidence
Technical details
Acceptance specificationAssay sensitivity ≤0.05 EU/mL
Confirmed methodLimulus Amebocyte Lysate (LAL) assay — USP
LaboratoryFreedom Diagnostics
Accession / document IDNot recorded
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.
05
PCR Microbial ScreeningBiological Contaminants
ResultNo detectable microbial DNA
PASS
View evidence
Technical details
Acceptance specificationNo detectable microbial DNA
Confirmed methodPCR-based microbial detection assay
LaboratoryFreedom Diagnostics
Accession / document ID2609119096
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.
06
Heavy Metals / Elemental ImpuritiesElemental Impurities
ResultPass — As, Cd, Pb, Hg below reporting/specification limits
PASS
View evidence
Technical details
Acceptance specificationBelow reporting/specification limits
Confirmed methodICP-MS
LaboratoryFreedom Diagnostics
Accession / document ID2609119096
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.
07
Fentanyl ScreeningAdulterant Screening
ResultNo fentanyl detected
PASS
View evidence
Technical details
Acceptance specificationNo fentanyl
Confirmed methodNot recorded
LaboratoryFreedom Diagnostics
Accession / document ID2609119096
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.
08
pH AnalysisPhysical Characterization
Result5.5
PASS
View evidence
Technical details
Acceptance specificationNot pre-registered
Confirmed methodNot recorded
LaboratoryFreedom Diagnostics
Accession / document ID2609119096
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.
09
Documented AppearancePhysical Characterization
ResultWhite Lyophilized Powder
PASS
View evidence
Technical details
Acceptance specificationConforms to documented lot description
Confirmed methodNot recorded
LaboratoryFreedom Diagnostics
Accession / document ID2609119096
Accreditation / scope statusNot represented by Osmora as ISO/IEC 17025-accredited scope.

Extended Analytical Framework

Seven additional checks are tracked independently. Pending work is never represented as completed and does not change the displayed Core Release Standard result.

0 / 7 documented · 16 total framework checks
10
Potency AssayIdentity & Composition
ResultPending
NOT SUBMITTED
Evidence pending
Technical details
Acceptance specificationNot pre-registered
Confirmed methodPending confirmation
LaboratoryPending confirmation
Accession / document IDNot recorded
Accreditation / scope statusNot assessed — laboratory or method remains pending.
11
USP SterilityBiological Contaminants
ResultPending
NOT SUBMITTED
Evidence pending
Technical details
Acceptance specificationNot pre-registered
Confirmed methodPending confirmation
LaboratoryPending confirmation
Accession / document IDNot recorded
Accreditation / scope statusNot assessed — laboratory or method remains pending.
12
Bioburden / Microbial EnumerationBiological Contaminants
ResultPending
NOT SUBMITTED
Evidence pending
Technical details
Acceptance specificationNot pre-registered
Confirmed methodPending confirmation
LaboratoryPending confirmation
Accession / document IDNot recorded
Accreditation / scope statusNot assessed — laboratory or method remains pending.
13
Residual SolventsProcess / Chemical Impurities
ResultPending
NOT SUBMITTED
Evidence pending
Technical details
Acceptance specificationNot pre-registered
Confirmed methodPending confirmation
LaboratoryPending confirmation
Accession / document IDNot recorded
Accreditation / scope statusNot assessed — laboratory or method remains pending.
14
TFA ContentProcess / Chemical Impurities
ResultPending
NOT SUBMITTED
Evidence pending
Technical details
Acceptance specificationNot pre-registered
Confirmed methodPending confirmation
LaboratoryPending confirmation
Accession / document IDNot recorded
Accreditation / scope statusNot assessed — laboratory or method remains pending.
15
Moisture / Water ContentPhysical Characterization
ResultPending
NOT SUBMITTED
Evidence pending
Technical details
Acceptance specificationNot pre-registered
Confirmed methodPending confirmation
LaboratoryPending confirmation
Accession / document IDNot recorded
Accreditation / scope statusNot assessed — laboratory or method remains pending.
16
Same-Lot ConformityBatch Consistency
ResultPending
NOT SUBMITTED
Evidence pending
Technical details
Acceptance specificationNot pre-registered
Confirmed methodPending confirmation
LaboratoryPending confirmation
Accession / document IDNot recorded
Accreditation / scope statusNot assessed — laboratory or method remains pending.

Reading the framework.A pending extended check is still pending. It is not a pass, certification, safety assessment, or completed analytical result.

Laboratory transparency

Who generated the data.

Laboratory identity, exact-lot methods and accession IDs are shown separately from accreditation. Accreditation is scope-specific; Osmora does not treat a laboratory credential as a blanket claim that every test falls within accredited scope.

Third-party analytical laboratory

Freedom Diagnostics

9 documented checks
Operating / entity identityFreedom Diagnostics Testing — public operating name
Location133 Holiday Ct, Suite 106 · Franklin, TN 37067 · USA
Methods on this lotLC-MS · HPLC-UV · Limulus Amebocyte Lysate (LAL) assay — USP · PCR-based microbial detection assay · ICP-MS
Accession / document IDs2609119096
Testing date in Osmora recordPending documentation
Public credential contextPublic site states ISO 9001 quality-management principles + GLP quality-standard principles

Scope note.Freedom Diagnostics publicly references ISO 9001 quality-management principles and GLP quality-standard principles. Osmora does not treat those statements as ISO/IEC 17025 laboratory accreditation or as proof that a specific peptide test is within an accredited scope.

Open issuer COA lookup ↗View laboratory website ↗Open original lot evidence ↓

Batch identity

Lot-specific record information.

This record applies only to the identified lot and the samples documented for it.

Lot / BatchIPA-26-001
Manufacturing datePending documentation
Testing datePending documentation
Document revision2.0

Sampling & custody

What was submitted.

Blank or undocumented fields remain visibly pending rather than being inferred.

Finished units submittedPending documentation
Sampling methodTwo finished vials from lot Osmora GH-26-001 were submitted for independent third-party analytical testing.
Chain of custodyReceived by Freedom Diagnostics 09/11/2026; analytical report issued 09/12/2026.
Retain sampleNot documented

Evidence library

Original evidence & audit trail.

Each source is mapped to the exact-lot checks that reference it. Missing metadata remains visibly unrecorded rather than inferred.

Published source document

Original Laboratory Report — Slot 1

Original source
Document typeOriginal third-party laboratory report
Issuer / laboratoryFreedom Diagnostics
Accession / document ID2609119096
Report dateNot separately recorded
Testing date in lot recordPending documentation
Methods linked to this sourceLC-MS · HPLC-UV · Limulus Amebocyte Lysate (LAL) assay — USP · PCR-based microbial detection assay · ICP-MS
Evidence chain
01 · Results9 documented results linked
02 · Lab / accessionFreedom Diagnostics · 2609119096
03 · Original sourceOriginal Laboratory Report — Slot 1
04 · Osmora reviewQuality review note published
Open original evidence ↗
9 mapped checks · View mapping

Identity Confirmation · HPLC / UPLC Purity · Vial Content / Quantity Assay · Bacterial Endotoxin · PCR Microbial Screening · Heavy Metals / Elemental Impurities · Fentanyl Screening · pH Analysis · Documented Appearance

Record integrityPublished record controls.
Published report SHA-256c86cad950f4aab8e28f528a4f6b273a4033ec5e5630e2d74004911e22afa5011
Public record last modifiedSeptember 21, 2026 · 11:12 pm

The current Open Batch Record schema stores one published-report SHA-256 at the lot-record level. Osmora does not assign that hash to an individual source file unless the underlying record explicitly does so.

Record history

Verification events.

Public status changes remain visible as part of the lot's record history.

  1. Batch record migrated to Open Batch Record System v4.0.
    Status: Testing Pending · Decision: PENDING

Quality review note.Independent third-party analytical results received from Freedom Diagnostics. Identity, purity, net content, endotoxin, PCR microbial screening, elemental impurities, fentanyl screening, pH, and appearance results are recorded above. Additional testing remains pending where indicated.

Lot-specific scope.Information shown here applies only to the identified lot and samples examined. This record is not approval for human or veterinary use and does not establish the status of any other lot.