Home » Finished Formulation » Metoclopramide Injection
| NAME OF PRODUCT : YASHINORM INJECTION 2 ML (METOCLOPRAMIDE INJECTION BP 5MG/ML) | |
| TEST | SPECIFICATION |
| Description | A clear colourless solution |
| Identification | Should comply as pr BP |
| Volume Variation | NLT 2.0 mL |
| pH | 3.0 to 5.0 |
| Particulate Matter | Sample should be free from particles |
| Sterility | Should comply as per BP |
| Related Substances | Should comply as per BP |
| Assay - Each mL contains: Metoclopramide HCl BP eq to Metoclopramide HCL- 5mg |
90.0% to 110.0% (4.50mg -5.50mg) |
| NAME OF PRODUCT : YASHIPROSTOL (Misoprostol Tablets 100 mcg) | |
| TEST | SPECIFICATION |
| Description | A white coloured, round shaped, slightly biconvex uncoated tablet with bisected line on one side and plain on other side. |
| Identification by IR | Should comply |
| Uniformity of weight | within ± 7.5% of average weight |
| Average Weight | 105.00 mg ± 3% |
| 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 15 min |
| Assay of | 90.0% to 110.0% of Label claim |
| NAME OF PRODUCT : YASHINALOX (Naloxone HCl) Injection USP 0.4 mg/ml - 1 ml | |
| TEST | SPECIFICATION |
| Description | Clear colourless aqueous solution filled in amber type I glass ampoule having blue dot on neck with paper label and sealed |
| Identification (HPLC) | Should comply as per USP The retention time of the major peak in the chromatogram of assay preparation corresponds to that of the standard preparation. |
| Average volume of 10 Containers | NMT 1.0 ml |
| Colour and clarity of solution | Should be clear and colourless aqueous solution |
| pH | 3.5 to 6.5 |
| Nominal Volume | NMT 1.0 ml |
| Limit of 2,2 Bisnaloxone | NMT 4.0 % |
| Particulate Matter | NMT 3000 of size 10µm and NMT 300 of size 25µm |
| Sterility test | To be sterile |
| Bacterial Endotoxins | NMT 500 USP EU/ mg of Naloxone HCl |
| Assay:
Each ml contains Naloxone HCl USP..0.4 mg |
90.0% to 110.0% |
| NAME OF PRODUCT : YASHIOM (Gasto resistant Omeprazole Capsules BP 20 mg) | |
| TEST | SPECIFICATION |
| 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 | 90.0% to 110.0% of Label claim |
| NAME OF PRODUCT : PERMETHRIN LOTION 5% | |
| TEST | Limits as per IHS |
| Description | White to off-white liquid. |
| Wt/ml | Complies IHS |
| Ph | 6.5 to 7.5 |
| Assay Permethrin........5 % |
90-110% of LA |
| NAME OF PRODUCT : YASHIDOL (TRAMADOL HCl INJECTION BP 100 MG/ML) | |
| TEST | SPECIFICATION |
| Description | A clear colourless solution |
| Identification | Should comply |
| Volume Variation | NLT 2.0 mL |
| Particulate Matter | Sample should be free from particles |
| Sterility | Should comply as per BP |
| Related Substances | Should comply as per BP |
| Assay - Each mL contains: Tramadol HCl - 25mg |
95.0% to 105.0% |
| NAME OF PRODUCT : YASHIVIT K (VITAMIN K-1 PHYTOMENADIONE INJECTION 10MG/ML) | |
| TEST | SPECIFICATION |
| Description | A golden yellow clear solution |
| Identification | Should comply |
| Volume Variation | NLT 1.0 mL |
| pH | 5.0 to 7.5 |
| Particulate Matter | Sample should be free from particles |
| Sterility | Should comply as per BP |
| Related Substances | Should comply as per BP |
| Assay - Each mL contains: Phytomenadione BP - 10 mg | 90.0% to 115.0% |
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