PRODUCT NAME
CLA Carnitine Soft Capsule
1. General Specification
No. |
Fields |
Specification |
1.1 |
Dosage form |
Soft capsule |
1.2 |
Size/Shape |
26 minim oblong |
1.3 |
Physical appearance |
Pending shell contains light yellow oily suspension. |
1.4 |
Average fill weight |
1350mg±7.5% |
1.5 |
Average shell weight |
550mg±7.5% |
1.6 |
Average total weight |
1900mg±7.5% |
1.7 |
Uniformity of mass |
NMT.2>7.5% &none>15% |
1.8 |
Disintegration |
Not more than 30 minutes. |
1.9 |
Storage conditions |
In a well closed container complied with food hygiene requirements, at 10 - 25°C and 35% - 65% R.H. |
1.10 |
Transportation |
Don’t mix or transport with toxic, hazardous, contaminative materials. Protect from impact, rain, sun and contaminations. |
1.11 |
Shelf Life1 |
3 years from date of manufacture |
2. Master Formulation
No. |
Active Ingredient |
Label claim /capsule |
Actual input /capsule |
Release limit |
2.1 |
L-Carnitine fumarate |
|
200.0mg |
|
Equiv. Carnitine |
116.00 |
|
90%-110% |
|
2.2 |
CLA 80%EE |
_ |
800.0mg |
|
Equiv. CLA |
640.0mg |
|
90%-110% |
No. |
Excipient |
Actual input/capsule |
2.3 |
Sunflower Oil |
269.0mg |
2.4 |
Beeswax |
54.0mg |
2.5 |
Lecithin |
27.0mg |
No. |
Capsule shell |
Quantity/capsule |
2.6 |
Gelatin (with 12% water) |
Pending |
2.7 |
Glycerol |
Pending |
2.8 |
Colorant |
Pending |
2.9 |
Puridied-water |
Pending |
3. Microbial Release Limits
No. |
Item |
Release limit |
3.1 |
Total viable aerobic count (TVAC) |
NMT. 1 x 104CFU/g |
3.2 |
Yeast and Mould Count |
NMT. 1 x 102CFU/g |
3.3 |
Enterobacteria |
NMT. 1 x 102CFU/g |
3.4 |
Salmonellae |
Not detected/10g |
3.5 |
Escherichia coli |
Not detected/g |
4. Purity Release Limits
No. |
Item |
Release limit |
4.1 |
Heavy metals |
NMT. 20ppm |