b.gangatharan


{ City } tiruchy
< Country > india
* Profession * sr.executive
User No # 123577
Total Questions Posted # 16
Total Answers Posted # 42

Total Answers Posted for My Questions # 17
Total Views for My Questions # 14224

Users Marked my Answers as Correct # 139
Users Marked my Answers as Wrong # 5
Answers / { b.gangatharan }

Question { 920 }

What is the difference between ROI & sulphates ash?


Answer

There is no difference b/w procedure,both are same. In Indian pharmacoepia it is called as ROI and in USP called it as sulphated ash.both are used for determination of content of inorganic mater in organic substance.
Thanks,
Gangatharan.B

Is This Answer Correct ?    2 Yes 0 No

Question { Alembic, 1217 }

What is difference between NDA & ANDA ?


Answer

NDA means New Drug Application,sponsor of new drug must submit evidence of drug safety&effectiveness to meet FDA requirements for marketing approval,hence sponsor submits to FDA a New Drug Application(NDA)......ANDA means Abbreviated New Drug Application which is an application for US generic drug approval for an existing licensed medication or approved drug.
Thanks,
B.Gangatharan,
Caplin Point laboratory,
Puducherry.

Is This Answer Correct ?    5 Yes 0 No


Question { Abbott, 1006 }

What is Rf value& Rx value in TLC?


Answer

Rf(Retardation factor) value is the ratio of distance travelled by solute to the distance travelled by the solvent front.
Rx value is nothing but the ratio of distance travelled by the sample and the distance travelled by the standard.
ThĂ nks,
B.Gangatharan,
Caplin point.

Is This Answer Correct ?    1 Yes 0 No

Question { Apotex, 1042 }

What is the difference between drug product and drug substance?


Answer

Drug substance is mostly composed of API or the naked drug without excipients.
Drug product is the formulated mixture of drug substance and excipients as the final marketed dosage forms like tablets,capsules etc...
Regards,
B.Gangatharan,
Caplin point Ltd,
Pudhucherry.

Is This Answer Correct ?    16 Yes 0 No

Question { Lupin, 759 }

What is excipient in drug product?


Answer

It is an inactive material in drug product which serve to package and deliver the Drug substance(API).
Thanks,
B.Gangatharan.
Caplin point Ltd.

Is This Answer Correct ?    7 Yes 0 No

Question { Abbott, 788 }

What is GF254 means in TLC plate?


Answer

G means Gypsum(13%caso4 hemihydrate)binder and F means flouresent indicator(1.5%) with maximum intensity of 254 nm.
Thanks,
B.Gangatharan,
Caplin point-unit-1

Is This Answer Correct ?    3 Yes 0 No

Question { Orchid, 511 }

What is zero water in TOC Analysis?


Answer

Organic carbon free water is called zero water.this water contains TOC level as 0 ppb.
Thanks,
Gangatharan.b
Caplin point - unit-1

Is This Answer Correct ?    3 Yes 0 No

Question { Lupin, 791 }

What is the name of the detector used in TOC?


Answer

Non dispersive IR detector.
Thanks,
B.Gangatharan,
Caplin point,unit-1

Is This Answer Correct ?    3 Yes 0 No

Question { Zydus Cadila, 606 }

What is NPOC method in TOC?


Answer

Non purgeable organic carbon.

Is This Answer Correct ?    3 Yes 0 No

Question { Lupin, 916 }

What is FDA form 482c?


Answer

FDA may conduct inspection on any plant for variety of reasons such as routine scheduled investigation or any other complaints,survey etc.,.during that time FDA investigator will present credentials and NOTICE OF INSPECTION(FDA FORM 482c) to concerned plant upon arriving..
Thanks,
B.Gangatharan
Caplin point Ltd, unit-1.

Is This Answer Correct ?    3 Yes 0 No

Question { 888 }

What are the class-1 residual solvents listed in ICH guidelines?


Answer

According to Q3c in ICH guidelines and USP Chapter <467> the following 4 solvents are listed .
1)Benzene
2)1,2-Dichloro ethane
3)1,1-Dichloroethene
4)1,1,1-Trichloroethane
Thanks,
B.Gangatharan
Caplin point Ltd,unit-1

Is This Answer Correct ?    3 Yes 2 No

Question { Lupin, 825 }

What are the concentration limit for class-1 residual solvents in ICH ?


Answer

1)Benzene(2ppm)
2)1,2-Dichloroethane(5ppm)
3)1,1-Dichloroethene(8ppm)
4)Carbon tetrachloride(4ppm)
5)1,1,1-Trichloroethene(1500ppm)
Ref:ICH Q3C Guidelines
Thanks,
B.Gangatharan,
Caplin Point,Unit-1

Is This Answer Correct ?    3 Yes 2 No

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