Clindamycin Hydrochloride
Short Description:
Product Detail
Product Tags
Description:
Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
Clindamycin Hydrochloride Capsules USP contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin.
Inactive ingredients: anhydrous lactose, magnesium stearate, starch (corn) and talc. The capsule shells contain: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 150 mg capsule shell also contains black iron oxide and yellow iron oxide.
Certificate of Analysis
| Product Name:Clindamycin Hydrochloride | Batch No.: 1911508 |
| Report No.: C-110011-15-0212 | Testing Date: 25, Nov. 2019 |
| Manufacturing Date: 19, Nov.,2019 | Expiry Date: 18, Nov., 2022 |
| Analysis Standard: USP41 | Quantity: 450kg |
| Testing Item | Specification | Results |
|
White crystalline powder; odorless |
Meet test |
|
Very soluble in water, slightly soluble in ethanol (96%). | Meet test |
|
IR: IR spectrum of sample should correspond to that of the reference standard |
Meet test |
| Reaction of Chloride: Positive |
Meet test |
|
|
Crystals |
Meet test |
|
+135°~ +150° |
+144° |
|
3.0 ~ 5.5 |
4.3 |
|
3.0~6.0% |
3.4% |
|
a) Clindamycin B: ≦2.0% |
0.17% |
| b) 7-Epiclindamycin: ≦4.0% |
0.28% |
|
| c) Any Other Impurity: ≦1.0% |
0.11% |
|
| d) Total Impurities: ≦6.0% | 0.65% | |
| 9. Assay | ≧800μg/mg (C18H33ClN2O5S,as is) |
901μg/mg |
| 10. Residual Solvent | a) Acetone: ≦5000ppm |
224ppm |
| b) Chloroform: ≦60ppm | Not Detected | |
| c) DMF: ≦880ppm |
Not Detected |
|
| d) Ethanol: ≦5000ppm |
Not Detected |
|
| 11. Microbiological Test | a) Total Aerobic Count: ≦100CFU/g |
<10CFU/g |
| b) Moulds and Yeasts: ≦10CFU/g |
<10CFU/g |
|
| c) Salmonella typhi: Absent |
Meet test |
|
| d) Staphylococcus Aureus: Absent |
Meet test |
|
| e) E. Coli: Absent |
Meet test |
|
| f) Pseudomonas Aeruginosa: Absent |
Meet test |
|
| 12. Bacterial Endotoxin | ≦0.6EU/mg |
<0.6EU/mg |
| 13. Residue on Ignition | ≦0.5% |
0.07% |
Conclusion: The above batch of Clindamycin hydrochloride fulfils the release specification.
