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| NAME OF PRODUCT : YASHITHER (Artemether & Lumefantrine Tablets) | |
| TEST | SPECIFICATION AS PER IH |
| Description | A yellow coloured, round shaped, beveled edged, uncoated tablet with break-line on one side & plain on other side. |
| Identification (HPLC) | Should comply as pr IHS The retention time of the major peaks in the chromatogram of the assay preparation should correspond to that with the chromatogram of std preparations as obtained in the assay. |
| Thickness | 3.40 mm ± 0.2 mm |
| Diameter | 8.00 mm ± 0.1 mm |
| Average Weight | 210.00 mg ± 3% |
| Uniformity of weight | within ± 7.5% of average weight |
| Disintegration Time | NMT 15 min in water medium at 37? |
| Hardness | NLT 3.0 Kg/cm2 |
| Friability | NMT 1.0% |
| Assay - Each uncoated tablet contains: | |
| Artemether - 20 mg | 90.0% to 110.0% (18.0mg -22.0mg) |
| Lumefantrine - 120 mg | 90.0% to 110.0% (108.0mg -132.0mg) |
| NAME OF PRODUCT : YASHISUNATE (ARTESUNATE INJECTION USP 100MG/2ML) | |
| TEST | SPECIFICATION AS PER USP |
| Description | A white powder along with solvent for injection. |
| Assay - Each uncoated tablet contains: | |
| Atresunate – 60 mg | 90.0% to 110.0% |
| NAME OF PRODUCT : YASHIRONE (Atovaquone & Proguanil Hydrochloride Tablets) | |
| TEST | Limits as per IHS |
| Description | Dark red coloured circular biconvex film coated tablet, plain on both sides |
| Identification (HPLC) | Should comply as per HIS RT of the major peaks in the chromatogram of the assay preparation should correspond to that with the chromatogram of standard preparation. |
| Average weight of 20 Tablet | 556.20 mg ± 5% |
| Uniformity of Weight | ± 5.0% of average weight |
| Thickness | 5.80 ± 0.20 mm |
| Diameter | 11.20 mm ± 0.10 mm |
| Disintegration Time | NMT 30 min |
| Dissolution | Atovaquone USP:NLT 70% Proguanil HCl USP:NLT 70% |
| Friability | NMT 1.0% |
| Assay - Each uncoated tablet contains: | 90.0% to 110.0% of L A |
| Atovaquone USP: 250mg | (225.0 mg to 275.0 mg) |
| Proguanil HCl BP:100mg | (90.0 mg to 110.0 mg) |
| NAME OF PRODUCT : Proguanil HCl BP:100mg | |
| TEST | SPECIFICATION |
| Description | A white coloured, round shaped, biconvex film coated tablet plain on both side. |
| Identification by IR | Should comply as per BP |
| Uniformity of weight | within ± 5% of average weight |
| Average Weight | 185.00 mg ± 3% |
| Thickness | 3.40 mm ± 0.2 mm |
| Diameter | 8.10 mm ± 0.2 mm |
| Disintegration Time | NMT 30 min |
| Dissolution | NLT 70.0% (Q) of LA |
| Related Substances | Should comply as per BP |
| Assay of Chloroquine Phosphate | 92.5% to 107.5% of Label claim |
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