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Certificate Of Analysis
PRODUCT:Atorvastatin Calcium
QUANTITY: 15g BATCH NO: 20230601
PACKING: 15g/Bag TEST DATE: 23.06.03
SOURCE: Warehouse REPORT DATE: 2023.06.4
MANUFACTURING DATE: 2023.06.03 EXPIPY DATE: 2025.06.02
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Test |
Acceptance Criteria |
Results |
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Description |
A white to off-white,crystalline powder |
White crystalline powder |
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Solubility |
Very slighty soluble in water,Acetonitrile, Slightly soluble in Methanol(95%).Soluble in Methanol,Soluble Dimethl dimethylSulphoxide |
Complies |
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Identification |
a.By IR Absorptiom b.By SOR c.By HPLC |
Complies |
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Specific Optical Rotation [α]D25,in DMSO |
Between-6.0 to -10.0 |
-7.6 |
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Water Content(By KF) |
Between 3.50% w/w to 5.0% w/w |
4.7% |
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Heacy Metals |
NMT 20 ppm (0.002%) |
＜20ppm |
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Calcium Content (On anhydros basis) |
Between 3.2% w/w to 3.8% w/w |
3.5 |
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Assay(By HPLC) Content of Atorvastatin Calcium |
99.0% w/w to 101.0% w/w |
99.3% |
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Enantiomeric Purity(By HPLC) |
NMT 0.20% |
0.04% |
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Related substances （By HPLC） |
Any known individual impurity: |
NMT0.15% |
0.14% |
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Any unknown individual impurity: |
NMT0.10% |
0.09% |
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Total impurity: |
NMT1.00% |
0.5% |
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Residual solvents (By GC) |
Ethanol |
NMT 5000ppm |
＜17ppm |
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Toluene |
NMT 890ppm |
92ppm |
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n-Hexane |
Nmt 290ppm |
4ppm |
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Microbial Limits
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Total acrobic microbial count |
NMT 1000cfu/g |
＜10cfu/g |
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Total yeast and mould count |
NMT 100cfu/g |
＜100cfu/g |
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Escherichia coli |
Should be absent in 1g |
ND |
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Salmonella spp |
Should be absent in 10g |
ND |
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Particle size dietribution |
d(0.9)-Not more than 10.0 microns |
9.0 micron |
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Conclusion：The product complies with USP35
