master formula record l-carnitine injection

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3 years ago

master formula record l-carnitine injection

master formula record l-carnitine injection Batch Size: 530 Liters

1.0 PRODUCT INFORMATION:

PRODUCT CODE
GENERIC NAME	L-Carnitine Injection
LABEL CLAIM	Each 5 ml contains
	L-Carnitine	1 gm
	Water for Injection	q. s.
STANDARD BATCH SIZE:	530 Liters
PRODUCT DECRIPTION	Clear ,colorless solution
STORAGE CONDITION	Store in a cool place. Do not freeze.

2.0. TABLE OF CONTENT:

Sr. No.	Contents
1	PRODUCT INFORMATION
2	TABLE OF CONTENT
3	BILL OF RAW MATERIAL & CALCULATION
4	BATCH MANUFACTURING PROCESS
5	PRECAUTION
6	YIELD AND ACCOUNTABILITY

3.0. BILL OF RAW MATERIAL:

Sr. No.	INGRADIENTS	Label clam	Standard Qty(Kg)	Overages(%)	Batch Qty(Kg)
1.0	Levocarnitine	1gm/5ml	111.300 kg	5%	111.300 kg
2.0	Hydrochloric Acid	–	0.650Ltr	–	0.650Ltr
3.0	Water for inj.(WFI)	q.s.	–	–	–

4.0. CALCULATION:
LABEL CLAIM:
Each 5 ml Contains:
L-carnitine USP 1gm
Water for Injection q.s.

Calculation for L-carnitine

R.No. One:_________________

Assay on Anhy. Basis: __________ % Water………………. %

L-carnitine USP= 200 x Batch Size x100 x100__=…. ………Kg of L-carnitine

— — — Assay x (100-Water) x1000

5.0. BATCH MANUFACTURING PROCESS:

Ensure That compounding Vessel is cleaned before starting the procedure.
Collect Water for Injection Batch Size according in a Mixing vessel (Temp 80-85°C)send BET sample
with continuous nitrogen Purging.
From the step 1st take Water for Injection Batch Size according a side in other SS vessel for final
volume make up.
Add and dissolve Levocarnitine with continuous stirring and check the clarity of solution.
Check the initial ph and adjust ph with 10% Hcl solution to(6.0 to 6.3) and finally make
up the volume with w.f.i.
Intimate the IPQA to collect Bulk solution and send to QC for analysis.
Bulk Solution pH -6.0 to 6.3 and Finished pH 6.0 to 6.5.
5.1. FILTRATION :
Ensure that Bulk solution Release from QC Department.
Filter the Bulk solution from Mixing Vessel to Collection Vessel through 0.2 micron sterilized filter.
Check the Pre and Post Filter Integrity.
5.2. FILL VOLUME DETAILS:
Fill volume for 5 ml Ampoule:
Standard fill volume -5.3 ml
Lower fill volume -5.1 ml
Upper fill volume -5.4 ml
5.3. PRECAUTION:
Ensure the nitrogen purging throughout the process.
Always use nose mask, hand gloves while processing.
All the contact parts of the Equipment, Filtration Assembly , Filling M/C parts and

Accessories should be sterilize, at the time of use.

6.0. YIELD AND ACCOUNTABILITY:
Bulk yield (After filtration) between 98 -100 %.
After Filling, Sealing and visual Inspection completion the % yield is NLT 90%.

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