PRODUCT SPECIFICATION

Product:
Specification Number : XYZ123 Ver. 2

S. No. Test Test Method Specifications

Release Stability
1 Appearance Visual Evaluation, USP Solid white to off-white cake, free
<1> from visible signs of
contamination.

2 Identification (TLC) USP <23> The Rf value of the principal spot

obtained from the solution under
test corresponds to that obtained
from the standard solution.

3 pH USP <791> 5.0 – 7.5, in a solution containing

5 mg per mL.

5 Residue on Ignition USP <281> Not more than 5.0 %

6 Loss on Drying USP <731> No more than 7.0 %

7 Heavy Metals USP <231> Not more than 0.01%

8 Uniformity of Dosage Units USP <905> Meets USP requirements for

sterile solids.

9 Microbial Assay USP <81> Not less than 80.0% and not more
than 120.0% of the labelled
amount

10 Sterility USP <71> Sterile

12 Particulate Matter USP <788>

≥ 10 µm Light Obscuration Not more than 6000 particles per
container
≥ 25 µm Not more than 600 particles per
container

13 Related Substances
Any Impurity HPLC, Ph. Eur. NMT 3.0%
Total Impurities NMT 17.0%

QA Approval: Effective Date:

Director Quality;___________________
Date: ___________________________ _________________
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