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User: Drkrishnasarmapathy Licence: by-sa
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Blob 5 Batch Analysis,Guidance to the manufacturer and th...

Created: 2016-09-10 09:21:16

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

~~The term ‘5 – batch analysis’ originates from the US EPA guidelines for testing of pesticides. The term is accepted now by most regulatory bodies like EEC, Indian registration authorities namely CIB & RC and other countries as well. There are no guidelines of OECD for this study. The study is essential to determine the composition of the product with respect to the active ingredient and its associated impurities.

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Blob SILDENAFIL CITRATE (Viagra) IN ITS POLYMORPHIC FORMS

Created: 2013-04-08 05:17:04

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

 AN IMPROVED PROCESS FOR THE PREPARATION OF SILDENAFIL CITRATE (Viagra) IN ITS POLYMORPHIC FORM The present invention provides an improved process for preparation of 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H –pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulphonyl]-4methypiperazine citrate (Sildenafil Citrate) ofPolymorphic form I)

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Blob STUDY OF QUANTIFICATION OF IMPURITIES AND RELATED SU...

Created: 2012-08-13 16:46:39

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

    Bulk drug during its production process, after its scale up, it is necessary to analyse for the presence of any impurities or related substances in it. This is to ensure the impurities and related substances are within their limits as per ICH Guidelines. The impurities and related substances are defined as; Impurity: Any component present in the drug substance or drug product which is not the desired product, a product-related substance, or excipient including buffer com...

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Blob Process for the preparation of amorphous atorvastati...

Created: 2012-07-24 12:07:03

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

Atorvastatin calcium is a drug compound that is used as a lipid-lowering agent, fortreating hypercholesterolemia. The compound has the chemical name[R-(R*,R*)]-2-(4-fluorophenyl)-3,ö-dihydroxy-5-(1-methylethyl)-3-phenyl-4-{(phenylamino)carbonyl}-1H-pyrolle-1-hepatonic acid, calcium salt (2:1) trihydrate. Pharmaceutical productscontaining crystalline atorvastatin calcium trihydrate are sold using the trademarkLIPITOR.

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Blob Novel polymorph of 5-cyanopthalide high purity inter...

Created: 2012-07-24 12:02:16

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

The present invention relates to obtaining a new polymorph of 5-Cyanophthalide in highly pure form (99.5 to 99.99%), which is an intermediate used forthe synthesis of citalopram& escitalopram both of which are potent antidepressant drugs.Moreover this new polymorph of 5-cyanophthalide does not contain impurities liketerephthalic acid & diphthalide derivatives.        

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Blob Enantioselective method of synthesizing methylphenid...

Created: 2012-07-24 11:51:52

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

Process for the preparation of enantioselective method of making methylphenidate and derivatives . The method involves use of a rhodium catalyst, and selectively produces the D-enantiomer of the methylphenidate derivative in excess of the L-enantiomer . Furthermore, the method selectively produces the threo-diastereomer in excess of the erythro-diastereomer. The method is thus suitable for synthesis of D-threo-methylphenidate (the biologically active form of this compound) and derivatives &...

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Blob Quality Assurance and GMP and ICH

Created: 2012-07-24 11:46:03

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

Quality Assurance is a planned and systematic approach to generate enough confidence in the quality of the product and processes in the long run as per the specifications." In this biog you will find post related to ICH, GMP and Quality related matters.

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Blob GLIBENCLAMIDE Complexes ( Complexes of Mg,Cr,Ni,Zn a...

Created: 2012-07-24 11:33:50 | Last updated: 2012-07-24 11:33:51

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

The N-acetyl derivative of β-phenethylamine is reacted with chlorosulfonic acid to form the para sulfonyl chloride derivative. This is then subjected to ammonolysis, followed by base-catalyzed removal of the acetamide. This is then acylated with 2-methoxy-5-chlorobenzoic acid chloride to give the amide intermediate. This is then reacted with cyclohexyl isocyanate to yield the sulfonylurea glibenclamide

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Blob HOW TO START ANALYTICAL METHOD DEVELOPMENT

Created: 2012-07-24 11:28:31

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

 A bulk drug during its production process, after its scale up, it is necessary to analyse for the presence of any impurities or related substances in it. This is to ensure the impurities and related substances are within their limits as per ICH Guidelines.The impurities and related substances are defined as; Impurity: Any component present in the drug substance or drug product which is not the desired product, a product-related substance, or excipient including buffer components. I...

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Blob DEFINITION “IMPURITY”

Created: 2012-07-24 11:18:54

Credits: User Drkrishnasarmapathy

License: Creative Commons Attribution-Share Alike 3.0 Unported License

Impurities are normally generated during the formation of Active PharmaceuticalIngredients and their intermediates. Chances of their generation during Drug Productsformation are less as formulation is a physical blending process. Care is taken that theseexcipients do not react with each other to produce the degradants. They may consist oforganic and inorganic, and define levels at which impurities/degradants should beidentified.ICH Q3A covers drug substances and Q3B covers drug products. Th...

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