Home » Finished Formulation » Amoxy Clav Tablets
| NAME OF PRODUCT : YASHICLAV (Amoxicillin and Potassium Clavulanate Tablets) | |
| TEST | SPECIFICATION AS PER USP |
| Description | A off white colored, oval shaped, biconvex, film coated tablet having both sides plain. |
| Identification (HPLC) | Should comply as pr IHS |
| Average Weight | 1.479 g ± 5% |
| Uniformity of weight | within ± 7.5% of average weight |
| Disintegration Time | NMT 30 min in water medium at 37? |
| Hardness | NLT 8.0 Kg/cm2 |
| Water | NMT 11.0% |
| Assay - Each uncoated tablet contains: Amoxicillin Trihydrate eq. to Amoxicillin USP - 875 mg Clavulanate Potassium eq. to Clavulanate - 125 mg |
90.0% to 1120.0% 90.0% to 120.0% |
| NAME OF PRODUCT : YASHICILLIN 500 (Ampicillin Capsules BP 500 mg) | |
| TEST | SPECIFICATION AS PER USP |
| Description | A maroon/yellow coloured size 0 hard gelatin capsule containing white coloured powder. |
| Identification: | Should comply as per BP |
| 1. By Colour Development 2. By TLC |
A magenta-violet colour should be produced immediately. The principal spot in the chromatogram obtained with test solution should be similar in position, colour and size with that of the chromatogram obtained with reference solution. |
| Average Net Content of 20 Capsules | 571.00 mg ± 3.0% |
| Uniformity of Net Weight | Within ± 7.5% of average weight |
| Disintegration Time | NMT 30 min in water at 37? |
| Related Substances: | Should comply as per BP |
| Total Impurity | In the chromatogram obtained with test solution: the area of any secondary peak should not be greater than the area of the principal peak in the chromatogram obtained with test solution (2) (1%) |
| Assay: Each capsule contains: Ampicillin Trihydrate BP eq. to Ampicillin anhydrous 500mg | 92.50% to 107.50% 462.50 mg to 537.50 mg |
| 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 mL contains: Atresunate – 60 mg |
90.0% to 110.0% . |
| 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 Lumefantrine - 120 mg |
90.0% to 110.0% (18.0mg -22.0mg) 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 mL 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 |
| Water content by KF | Atovaquone Proguanil Tablets |
| 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% |
| Assay by HPLC
Each film coated Tablet contains Atovaquone USP: 250mg Proguanil HCl BP:100mg |
90.0% to 110.0% of L A (225.0 mg to 275.0 mg) (90.0 mg to 110.0 mg) |
| 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% |
| Assay by HPLC Each film coated Tablet contains Atovaquone USP: 250mg Proguanil HCl BP:100mg |
90.0% to 110.0% of L A (225.0 mg to 275.0 mg) (90.0 mg to 110.0 mg) |
| NAME OF PRODUCT : YASHIAZEE (Azithromycin Tablets 250 mg) | |
| TEST | SPECIFICATION AS PER USP |
| Description | A white coloured, round shaped, biconvex, film coated tablet plain on both 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. |
| Average Weight | 42745 mg ± 3% |
| Uniformity of weight | within ± 5% of average weight |
| Disintegration Time | NMT 30 min in water medium at 37? |
| Friability | NMT 1.0% |
| Assay - Each film coated tablet contains: Azithromycin Dihydrate eq to Azithromycin Base......250 mg |
90.0% to 110.0% |
| NAME OF PRODUCT : YASHICEF 200 [Cefixime Tablets USP] | |
| TEST | SPECIFICATION |
| Description | A white coloured, round shaped, biconvex, film-coated tablet, bisected on one side & plain on other side. |
| Identification By HPLC | Should comply as per USP The RT of the major peak for cefixime in the chromatogram of the assay preparation should correspond to that in the chromatogram of the standard preparation as obtained in the assay. |
| Thickness | 4.20 mm ± 0.2 mm |
| Diameter | 9.60 mm ± 0.2 mm |
| Average Weight | 313.0 mg ± 3.0% |
| Uniformity of weight | within ± 5.0% of average weight |
| Water | NMT 10.00% |
| Disintegration Time | NMT 30 minutes |
| Dissolution | NLT 75.0% (Q) |
| Assay - Each film-coated tablet contains: Cefixime USP eq to anhydrous Cefixime 200 mg | 90.0% to 110.0% of Label claim |
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