PREPARATION OF ASCORBIC ACID INJECTION.

AIM: To prepare, evaluate and submit two ampoules of ascorbic acid injection i. P. (each
containing 2ml).

Requirements: ampoules ( 2ml capacity each), ascorbic acid, para chloro meta cresol, sodium
bicarbonate, water for injection, measuring cylinder, beaker, syringe with needle, filter and ph
paper/ ph meter etc.

FORMULA:

INGREDIENT OFFICIAL FORMULA WORKING FORMULA

ASCORBIC ACID I.P. 25GM

SODIUM BICARBONATE 14.58GM
P-CHLORO M-CRESOL 0.1GM
WATER FOR INJECTION Q.S. TO 100ML

THEORY:

ASCORBIC ACID INJECTION IS A CLEAR, COLOURLESS, STERILE SOLUTION OF

ASCORBIC OR SODIUM ASCORBATE. ASCORBIC ACID INJECTION IS ALSO KNOWN
AS VITAMIN C INJECTION.ASCORBIC ACID ACTS AS AN ANTISCORBUTIC AGENT.
ASCORBIC ACID IS FREELY SOLUBLEIN WATER AND STABLE AT PH 5.4 AND ITS PH
IS MAINTAINED BY USING SODIUM BICARBONATE BECAUSE IN ACIDIC MEDIA IT
MAY GOES TO OXIDATION. IT IS STRONG ANTIOXIDANT OR REDUCING AGENT. IT
IS GRADUALLY DARKEN TO ON CONTINUOUS EXPOSURE TO LIGHT BUT ITS
THERAPEUTIC ACTTION IS NOT AFFECTED. SODIUM BICARBONATE IS USED AS
SOLUBILISING OR EFFERVESCENCENT. P-CHLORO M-CRESOL ACTS AS
PRESERVATIVE AND WATER FOR INJECTION IS USED AS VEHICLE.

PROCEDURE:
 AS PER THE REQUIRED VOLUME CALCULATE THE QUANTITY OF

INGREDIENTS.

 WEIGH ALL THE REQUIRED INGREDIENTS AND PERFORM THE

MANUFACTURING WORK IN ASEPTIC AREA.

 CLEAN THREE AMPOULES OF TYPE I OR TYPE II GLASS WITH DETERGENT

SOLUTION THEN WITH DISTILLED WATER.

 NOW PUT IN INVERTED POSITION IN BEAKER CONTAINING WATER AND

BOIL FOR 15 MINUTES, REMOVE AND DRY IN HOT AIR OVEN.

 TAKE 2/3 VOLUME OF WATER IN A BEAKER AND ADD REQUIRED

QUANTITY OF ASCORBIC ACID WITH CONTINUOUS STIRRING.

 ADD SODIUM BICARBONATE SLOWLY WITH STIRRING TO PRODUCE

EFFERVESCENCE.

 AFTER COMPLETION OF EFFEREVESCENCE ADD REMAININGQUANTITY OF

SODIUM BICARBONATE AND CONTINUE THIS PROCESS TILL ASCORBIC

ACID DISSOLVES COMPLETELY.

 ADD P-CHLORO M-CRESOL AND KEEP STIRRING TO DISSOLVE AND ADJUST

THE PH 5.7.

 FILTER THE SOLUTION THROUGH G4 FILTER.

 RINSE THE SYRINGE WITH WATER FOR INJECTION FOLLOWED BY DRUG

SOLUTION AND FILL WITH DRUG SOLUTION.

 TRANSFER THE DRUG SOLUTION INTO AMPOULE SLOWLY BY INSERTING

THE NEEDLE UPTO THE BOTTOM OF THE CONTAINER WITH AVOIDANCE OF

 AIR BUBBLES. THE LENGTH OF NEEDLE SHOULD BE LARGER THAN THE

LENGTH OF AMPOULE.

 SEAL THE AMPOULE BY PULL SEALING OR TIP SEALING METHOD. USING

PULL SEALING METHOD KEEP TIP OF THE AMPOULE ON FLAME WITH

ROTATION WHILE HOLDING THE AMPOULE IN THE LEFT HAND. THE TIP IS

LEFT IN THE FLAME FOR ONE OR TWO SECONDS AND REMOVED. THE TIP

SHOULD BE SMOOTH AND EVENLY ROUNDED.

 STORE IN A SEPARATE SIDE WITH SAFETY.

LABEL:

ASCORBIC ACID INJECTION INJECTION I.P.

USE: Used In The Prevention And

Composition : Lic. No …………..
Treatment Of Scurvy.
Each 2 ml ampoule contains:
Batch No …………..
Storage: Store in a cool place Ascorbic Acid I.P- 25% W/V
Mfg Date …………..
Direction :
DOSAGE: As directed by
Exp Date …………..
Discard, if any particulate matter is physician.
M.R.P. …………..
present.

Prepared by: ………………………………………….

EVALUATION OF ASCORBIC ACID INJECTION:

Sl No Tests Specification Observation Inference

1 Assay Ascorbic Acid injection contains not less than

95% w/v and not more than 115% w/v of the stated

amount of Ascorbic Acid.

2 Volume 2ml

3 Particulate Absent

matter

4 Appearance Clear

5 Tip Sharp /round

6 Leakage No

7 PH 5.5-7.0