CERTIFICATE OF ANALYSIS
NAME OF PRODUCT: CLINDAMYCIN HCL BATCH NO.: 990525
MFG. DATE: MAY, 1999 QUANTITY: 100G (SAMPLE)
EXP. DATE: MAY, 2002 REPORT DATE: JUL 17, 1999
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ITEMS |
STADARDS |
RESULTS |
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APPEARANCE: |
A WHITE OR ALMOST WHITE CRYSTALLINE POWDER |
PASS |
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IDENTIFICATION: |
AS STIPULATED |
PASS |
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SOLUBILITY: |
AS STIPULATED |
PASS |
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PH: |
3.0 – 5.0 |
4.1 |
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SPECIFIC ROTATION: |
+135 - +150° |
+144° |
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WATER: |
3.0 – 6.0% |
4.7% |
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SULFATED ASH: |
0.5% MAX. |
0.02% |
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ASSAY: |
84.0 – 93.0% |
87.6% |
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RELATED SUBSTANCES: |
1) TOTAL IMPURITIES: 3.0% MAX 2) MAX IMPURITY: 2.0% MAX. |
2.7% 1.9% |
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CONCLUSION: CONFORMS TO BP93 (BY GC) |
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