More than Just Lines on a Map: Best Practices for U.S Bike Routes
4 api
1. M.PHARM + MBA PHARMACEUTICAL ANALYSIS (2011-2012)
Title:- 4 API from U.S.P 30-NF35
Roll No-08 Name:-RavalJIgar
Date-10/12/11 Page no :
Name USP Isocratic
Referance System
Of page Column Mobile Phase / Detector Acceptance Criteria
Standard Suitably Parameter
Drug no. Gradient
Theophylline L1 column 4.0 Acetonitrile: Buffer Uv USP Not less than 97.0 Retention time 1.6min
mm × 30 cm solution (7:93) detector Theophylline percent and not more
Buffer (2.72 gm Na wavelengt RS than 102.0 percent RS NMT 2.0
acetate trihydrate h :280nm
+ 10ml glacial T.F NMT 2.0%
acetic acid & make
up the volume
2000ml with
water)
Triamicinolone L1 column 3.9 Methanol: Water Uv USP Not less than 97.0 R.S.D NMT 2.0%
mm × 30 cm (60:40) detector Triamicinolo percent and not more
wavelengt ne RS than 102.0 percent RS NLT 3.0
h:254nm
2. M.PHARM + MBA PHARMACEUTICAL ANALYSIS (2011-2012)
Title:- 4 API from U.S.P 30-NF35
Roll No-08 Name:-RavalJIgar
Date-10/12/11 Page no :
Tolcapon L1 column 4.0 Prepare a 230-nm USP Not less than 98.5 The relative standard
mm × 25 cm mixture of 0.01 Tolcapon percent and not more deviation for replicate
M Sodium 1- RS. than injections is not more than
octanesulfonate 101.5percent 3.0%.
solution, USP
acetonitrile, Tolcaponre
glacial acetic lated
acid, and compound
triethylamine A RS.
(81:19:2:0.5).
USP
Tolcapon
related
compound
B RS.
Betaxolol 4.6-mm × 15- Prepare a 273-nm USP Not less than 98.5 The relative retention
Hydrochloride cm column suitable filtered detector Betaxolol percent and not more times are about 0.9 for
that contains and degassed Hydrochlori than 101.5 percent alprenolol and 1.0 for
5-μm packing mixture of Buffer de RS. betaxolol; the resolution,
L1. and acetonitrile R, between the two peaks
(85:15) is not less than 1.0;
the tailing factors for the
two peaks are not more
than 2.0; and the relative
standard deviation
for replicate injections is
not more than 2.0%.