Generic name: Calcium phosphate & vitamin-D3 Suspension

Composition:- Each 5ml contains:

Vitamin D-----------------------400 i.u
Ossein mineral complex-----------250mg eq. to
Calcium--------------------------53.5mg Phosphorus-----------------------------24.8mg
Residual mineral salts--------7.5mg Collagen--------------------------------67.5mg
Other proteins-----------------20mg
Ref. Inhouse specs
Sr. # Tests▼ Specifications▼

1. Orange color suspension free from visible

Description
impurities with pleasant odour.
2. Identification Vit.D & Calcium should be identified
3. PH 6.0 to 8.5
4. Average volume / bottle 60ml ± 5%
90.0- 120.0%.of the stated amount
5.
Assay (Vit. D Contents)
360 i.u to 520 i.u / 5ml
90.0- 120.0%.of the stated amount
6.
Assay (Calcium Contents)
48.15mg to 69.55 mg / 5ml

Prepared by: Reviewed by: Approved by:

(Analyst) ( Sr.QC Officer) (Quality Control. Manager)

Signature Signature Signature

1-Description: Orange color suspension free from visible impurities with pleasant odour.
2- Identification: As per procedure for assay contents.
3- pH:
Measure the pH on calibrated pH meter
4- Average volume / bottle:
Take 10 bottles, Measure the volume on calibrated cylinder, calculate average volume per bottle.
5-Assay (Calcium contents)
Take 5ml of eq. to about 53.5mg of calcium, cool add 15ml HCl 20%, add 10ml of water.
+ 20ml of Ammonium chloride buffer, add few drops of eriochrome black indicator and
titrate with 0.10M EDTA VS . and calculate the contents of calcium. Each ml of 0.10M EDTA is
equivalent to 0.004gm of Ca++ .

Titre= to = ml of 0.10M EDTA VS (B # )

Titre x 0.004 x 100 x = %

53.5 of the stated amount

Determined quantity of Ca++ mg per tablet

X 53.5 = mg / 5ml
100

6- Assay (Vitamin D3 contents): By UV method:

Standard Preparation:
Take colecalceferol (vit. D3) RSD/W.std 10 mg in 50 ml volumetric flask dissolve and make up the
volume with ethanol further dilute 2ml to 10ml with ethanol. (0.04mg/ml)
Sample Preparation:
Take 5ml of suspension eq. to colecalceferol (vit. D3) 4.0 mg in 100 ml volumetric flask dissolve and
make up the volume with ethanol, sonicate for 5 minutes, filter. (0.04mg/ml)
Measure the absorbance of solutions @ 265 nm on U.V Spectrophotometer.
Sample abs. x 100 = %
Std. absorbance. of the stated amount
Determined quantity of Vitamin D3 per 5ml

X 400 = I.U / 5ml

100