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Yashica Pharmaceuticals
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Yashica Pharmaceuticals

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Home » Finished Formulation » Amoxy Clav Tablets

Amoxy Clav Tablets

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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%

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Ampicillin Tablets

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

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Artemether & Lumefantrine Tablets

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)

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Artesunate Injection

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%












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Atovaquone Proguanil Tablets

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)

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Atovaquone Tablets

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)

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Azithromycin Tablets

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%

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Cefixime Tablets

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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