4.2.1Practice site, made-up data

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HV-24-0121 · Metformin HCl 500 mg tablets

Sample HV-24-0121 logged. Status: Logged, awaiting testing.

Product
Metformin HCl 500 mg tablets
Batch
MF-2410-08
Purpose
Release
Specification
SPEC-MF500 v7
Quantity received
60 tablets
Storage
Room temperature, 15 to 25 °C
Logged by
Q. Reviewer
Status
Logged
Tests
TestAcceptance criteriaResultStatus
Identification (IR)Conforms to reference spectrumNot started
Assay (HPLC)95.0 to 105.0 % of label claimNot started
Water (KF)NMT 0.5 % w/wNot started
Dissolution, 30 minQ NLT 80 %Not started
Uniformity of dosage unitsAcceptance value NMT 15.0Not started