ADENOSINE INJECTION

ADENOSINE INJECTION:
(3 mg / ml)
Batch Size : 100 Lts
Raw Material Qty.
Adenosine 300 gms
Sodium Chloride 900 gms
Water for Injections 100 Lts
pH : 4.5 - 7.5
Manufacturing Process :
  1. Take Water for Injection in a suitable SS Vessel.
  2. Cool it to 40 C
  3. Add Sodium Chloride and stir to dissolve.
  4. Add adenosine and stir to dissolve completely.
  5. Check the pH
  6. It shall be between 4.5 - 5.5
  7. If not add dilute HCl and adjust require value ( 5.0 )
  8. Sterilize by filteration from 0.22 micron membrane.
  9. Fill into 2 ml Vials under nitrogen throughly.
  10. Plug with sterile butyl plugs and apply aluminium seal.
ADENOSINE

C1-H13N5O4 267.25
6-Amino-9-b -D-ribofuranosyl-9-H-purine
9- b-D-Ribofuranosyladenine [ 58-61-7 ]
Adenosine contains not less than 99.0 percent and not more than 101.0 percent of C10H13N5O4, calculated on the dried basis.
Packaging and storage-Preserve in well-closed, light-resistant containers.
USP Reference standards (11}-USP Adenosine RS.
Identification-Injrared Absorption (197M).
Melting range (741): between 233° and 238°.
Specific rotation (781S): between -68.0° and -72.0°.
Test solution: 20 mg per mL in sodium hydroxide solution (1 in 20), determined on a test specimen previously dried at 105° for 2 hours.
Acidity or alkalinity-Suspend 1 9 in 20 mL of carbon dioxide- free water. Stir for 30 seconds, and filter through a coarse filter. To each of two 10-mL portions of the filtrate add.0.1 mL of bromocresol purple TS. Not more than 0.3 mL of 0.01 N sodium hydroxide is required to produce a blue-violet color in one portion, and not more than 0.1 mL of 0.01 N hydrochloric acid is required to produce a yellow color in the other portion.
Loss on drying (731)-Dry it at 105° for 2 hours: it loses not more than 0.5% of its weight.
Heavy metals, Method II (231): 0.001%.
Limit of ammonia-Suspend 0.5 g in 10 mL of water. Stir for 30 seconds, and filter through a coarse filter. Dilute the filtrate with water to 15 mL, mix, and use the filtrate as the test solution. Dilute I mL of ammonium chloride solution (314 in 1000) with 100 mL of water. Mix 2 mL of this ammonia standard solution with 13 mL of water, and use this as the reference solution. To the test solution and the reference solution add 0.3 mL of alkaline mercuric-potassium iodide TS, cap the test tubes, and allow to stand for about 5 minutes: the test solution does not exhibit a more intense yellow color than that of the reference solution (not more than 0.0004% .ammonia).
Limit of ch1oride-Suspend 0.2 g in 10 mL of water. Stir for 30 seconds, filter through a coarse filter, and use the filtrate as the test solution. Prepare a chloride standard solution by diluting 1 mL of sodium chloride solution (231 in 1000) with 100 mL of water. To the test solution and 10 mL of the chloride standard solution add 1 mL of nitric acid and 1 mL of silver nitrate TS, dilute each solution than 2.0, and the relative standard deviation for replicate injections is not more than 2.0%
Procedure : Searately inject equal volumes (about 20 ml ) of the Standard preparaiton and the Assay preparation into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the quantity in mg of C8H11N5O3 in the portion of Ointment taken by the formula :
100 C ( rU / rS ),
in which C is the concentration, in mg per ml, of USP Acyclovir RS in the Standard preparation and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation respectively.
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