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Home » Finished Formulation » Metoclopramide Injection

Metoclopramide Injection

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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)


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Misoprostol Tablets

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

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Naloxone Injection

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%

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Omeprazole Capsules

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

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Permethrin Lotion

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








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Tramadol Injection

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%




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Vitamin K Injection

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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