Yashica Pharmaceuticals Private Limited
Thane, Maharashtra
GST 27AAACY3217A1ZT
TrustSeal Verified
IndiaMART Verified Exporter
Approx. Rs 40 / Stripe
Description | White circular flat beveled edged uncoated tablet having break line on one side of each tablet. |
Test Items | Limits |
Average Weight | Meets the Requirement |
Identification A. By IR B. By TLC |
Meets the Requirement Meets the Requirement |
Uniformity of weight | Meets the Requirement |
Disintegration Time | NMT 15 Min |
Related Substance (By HPLC) Impurity C The sum of this divided area &the area of any other secondary peaks |
NMT 0.3 %
NMT 0.5 % |
Approx. Rs 150 / Box
TEST | SPECIFICATION |
Description | A white coloured, round shaped, biconvex, bisected on one side, uncoated sublingual tablet |
Identification A. By TLC
|
The principal spot in the chromatogram obtained with test solution should be similar in size, position and colour that obtained with reference solution |
B. By HPLC | The RT of the major peak in the chromatogram of the assay preparation should correspond to that of the chromatogram of the standard preparation as obtained in the assay |
Thickness | 3.50 mm ± 0.2 mm |
Diameter | 6.00 mm ± 0.2 mm |
Average Weight | 120.50 mg ± 3.0% |
Uniformity of weight | within ± 7.5% of average weight |
Disintegration Time | NMT 2 minutes |
Hardness | NLT 3 Kg/ cm2 |
Friability | NMT 1.0% |
Uniformity of Content | 75.0% - 135.0%
|
Assay - Each uncoated sublingual tablet contains Diluted Nitroglycerin USP eq. to Nitroglycerin 0.5mg | 90.0% to 115.0% of Label claim (0.45 mg - 0.575 mg) |
Approx. Rs 100 / Pack
NAME OF PRODUCT : YASHISORBI (Isosorbide Dinitrate Sublingual Tablets USP 5 mg) | |
TEST | SPECIFICATION AS PER USP |
Description | A white coloured, round shaped, biconvex uncoated sublingual tablet plain on other side. |
Identification by IR | Should comply as per USP |
Uniformity of weight | within ± 7.5% of average weight |
Average Weight | 100.00 mg ± 7.5% |
Hardness | NLT 2.0 kg/cm2 |
Thickness | 3.00 mm ± 0.2 mm |
Diameter | 6.00 mm ± 0.2 mm |
Friability | NMT 1.0 % |
Uniformity of Content | 85.0% to 115.0% |
Disintegration Time | NMT 2 min |
Dissolution | NLT 80.0% (Q) of LA |
Related Substances | Should comply as per BP |
Assay of Isosorbide Dinitrate | 90.0% to 110.0% of Label claim |
We will contact you soon !
Sanjay Totre
(Managing Director)
Yashica Pharmaceuticals Private Limited
Syndicate, Thane,
Maharashtra,
India