AMPICILLIN SODIUM INJ 100 and 500 MG

AMPICILLIN SODIUM INJ 100 and 500 MG:
AMPICILLIN SODIUM INJ 100
FORMULA

Sr. No.	Ingredients	Qty
	Ampicillin sodium	115.00 mg.
	Diluents	Nil

To compensate the loss on storage and during processing overage of 10 % has been included in the formulation.
371.39 gms. of Ampicillin sodium = 349.40 gms. of Ampicillin Anhydrous.
100 mg. of ampicillin anhydrous = 106.29 gms. of Ampicillin sodium.
AMPICILLIN SODIUM INJECTION IM/IV
500 MG.
FORMULA

Sr. No.	Ingredients	Qty
	Ampicillin sodium I.P.	580 mg.
	Diluents	Nil

To compensate the loss approx 10 % has been included.
500 mg. of Ampicillin Anhydrous is approximately equal to 532 mg. of Ampicillin sodium.
PLEASE NOTE

1. Obtain Ampicillin sodium sterile from the reliable dealer.mfger only.
2. Check carefully date of mfg./expiry/batch No. Do not accept any material which is :
   Near to expiry
   Batch No is not clear
   The pack is soiled or broken
   The pack is not marked as sterile.
   
3. Store Ampicillin Bulk in a clean, cool place away from direct sunlight / heat radiation. Protect the bulk from moisture.
4. Ampicillin sodium injection shall be expiry dated. The expiry shall not be more than 24 months from the date of mfg.
5. As per schedule P :
   Maximum shelf life for ampicillin sodium bulk is 3 years.
   Maximum shelf life for ampicillin sodium injection is 2 years.
   Hence ampicillin sodium bulk
   Which had already been shelved for one year shall not be used.
   
   
6. Ampicillin injection shall be prepared an area specially reserved for penicillin preparations.
7. Machine operators/chemists who can come in direct contact with ampicillin dust shall use proper face masks.
8. Direct contact with skin shall be avoided (Ampicillin sodium powder in contact with skin can cause sensitization )
   Carryout the assay for ampicillin content as per I.P. page No.
   Calculate the proportionate amount of ampicillin for each container.
   Find out % deviation.
   For 100 mg. Ampicillin sodium vial % deviation shall not be more than ± 10 %.
   For 250 mg vials it shall not be more than ± 7.5 %.
   For 500 mg vials it shall not be more than ± 5 %.
   (Out of 10 containers atleast 9 container shy comply to above limits.
   However, one container out of 10 may show deviation upto the twice the limit shown above).
   
9. Uniformity of weight :
   Take 10 containers.
   Remove the adherent label.
   Wash and dry the outside.
   Open the container and without delay weigh the container as completely as possible by gentle tapping, rinse if necessary with water, and them with alcohol and dry at 105 C. for one hour.
   Allow to cool in dessicator and weigh.
   The difference in weight represents the weight of the contents.
   Determine the average weight.
   Not more than two of the individual weights shall deviate from the average weights shall deviate from the average weight by more than 10 % and none deviates by more than 20 %.
   
10. Content of active ingredients :
    Determine the weight of the contents of 10 containers. Mix the contents.