Name of the laboratory :Quality Control Department

Karasapaca Köyü 2. Cad. Hamdard Binası No:17 Tosya O.S.B.

Registration number of
certificate
Sample information
Tosya/KASTAMONU
Phone : 0366 502 00 13 - 15
Email : fabrika@hamdard.com.tr
: Max-01/2020/ Max-01
Name of the product: MAXILIV COLLAGEN MAX - C 7000 MG 30 SACHET.
Generic Name: Hydrolyzed Collagen +Glucosamine+MSM(Methyl sulphonyl
methane)+Vitamin C + Hyaluronic acid
Dosage form: 7000 mg granules

Batch number: 01082020

Date of manufacture: 05-08-2020

Expiry date: 04-08-2020

Name and address of : Bağlar Mah. Gül Sok. No:27 Güneşli-Bağcılar / İstanbul
manufacturer Phone : 0212 630 30 46, +905366694848
Email : info@hamdard.com.tr / tolgametinel@gmail.com

QUANTITATIVE ANALYSIS

Name of the ingredients %W/W Amount per sachet (mg)

Hydrolyzed Collagen of High Purity 57.143 4000.000

Glucosamine HCL 7.143 500.000

MSM (Methyl sulphonyl methane) 7.143 500.000

Hyaluronic acid 0.143 10.000

Vitamin C (Ascorbic acid) 1.143 80.000

Sucralose 0.143 10.000

Maltodextrin 26.600 1862.000

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Apple flavor 0.357 25.000

Aerosil-200 / Silicon dioxide (E551) 0.043 3.000

Beta-carotene color 0.143 10.000

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 PHYSICAL AND CHEMICAL PROPERTIES
TEST PARAMETERS SPECIFICATION REFERENCE RESULTS
Description Red yellow colored and white In-house Complies
color granules
Identification Must comply with the positive In-house
test for : Hydrolyzed Collagen of
High Purity +ve
Glucosamine +ve
MSM(Methyl sulphonyl methane) +ve
Vitamin C(Ascorbic acid) +ve
Hyaluronic acid as Ph.Eur +ve
Color Red yellow In-house Complies
Odour Apple In-house Complies
Taste, after-taste and Sweet and sour In-house Complies
mouth-feel
Physical form Granules In-house Complies
Melting temperature 35.8–37.3ºC In-house Complies
Polymorphism Exist in two or more crystalline In-house Complies
forms with different
arrangements or conformations
of the constituents in the crystal
lattice.
Aqueous solubility 0.2–70.6 μg/min/cm2 In-house Instantly Soluble
Active drug stability Soluble In-house Complies
Appearance of solution A clear lite yellow transparent In-house Complies
solution
PH One tablet in 200 ml of purified European 4.64
water at 20 ± 1 °C by using pH Pharmacopoeia
meter
CO2 content 7.98- 8.763 European Not applicable
Meets European Pharmacopeia Pharmacopoeia
Standard.

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% Of LOD (Loss on Drying) NMT 3 % In-house 2.5%
Average Weight 7000mg In-house 7000mg

Uniformity of Weight Not more than ( 5 %) from the European + 1.5 % & -0.82 %
average mass. Pharmacopoeia
Disintegration Time Not more than European 2 minutes
≥5 minutes. Pharmacopoeia
Uniformity of Content: Meets European Pharmacopeial USP Complies
Standard. (5 sachet were
selected randomly. Each sachet
was transferred into a 50mL
volumetric flask, dissolved and
diluted to 50 mL with phosphate
buffer pH 6.8. One ml of this
solution was diluted to 100 ml
with phosphate buffer pH 6.8. The
amount of drug present in each
tablet was determined by UV
spectroscopy at 246 nm. Active
less than 25mg or 25 %.)
Dissolution Studies Not less than 80% released USP Complies
within 60minutes.
(The release rate from mouth
dissolving sachet was
determined using USP
Dissolution Testing Apparatus II
(Paddle type). The dissolution
medium used was 900 ml of
phosphate buffer pH 6.8 which
was maintained at 37±0.50C. The
paddle speed was kept at 50 rpm
throughout the study. Five ml of
samples was withdrawn at every
5 minutes interval and diluted to

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 10ml then 5ml of fresh
dissolution media maintained at
the same temperature was
replaniced. The samples were
analyzed spectrophotometrically
at 246nm using phosphate buffer
pH 6.8 as blank. The raw
dissolution data was analyzed
for calculating the amount of
drug released and percentage
cumulative drug released at
different time intervals.)
MICROBIOLOGICAL ANALYSIS
TEST PARAMETERS SPECIFICATION REFERENCE RESULTS
Total Aerobic Bacterial < 103 cfu/g USP (U.S Complies
Count Pharmacopeia)
Total Yeast and Mold Count < 102 cfu/g USP (U.S Complies
Pharmacopeia)
E. coli < Absent / 10 g USP (U.S Absent
Pharmacopeia)
Salmonella < Absent / 10 g USP (U.S Absent
Pharmacopeia)
Staphylococcus Aureus < Absent / 10 g USP (U.S Absent
Pharmacopeia)
HEAVY METAL ANALYSIS
TEST PARAMETERS SPECIFICATION REFERENCE RESULTS
Lead ≤ 03 ppm (European Complies
Pharmacopeia)
Cadmium ≤ 1 ppm (European Complies
Pharmacopeia)
Mercury ≤ 0.1 ppm (European Complies
Pharmacopeia)

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 ALLERGENS
TEST PARAMETERS SPECIFICATION REFERENCE RESULTS
Egg ≤ 5.0 ppm FDA Absent
Gliadin (Corn, Gluten) ≤ 10.0 ppm FDA Absent
Milk ≤ 5.0 ppm FDA Absent
Peanut ≤ 5.0 ppm FDA Absent
Shellfish (crustacean) ≤ 5.0 ppm FDA Absent
GENETICALLY MODIFIED ORGANISMS (GMOs)
TEST PARAMETERS SPECIFICATION REFERENCE RESULTS
(GMOs) NON-GMO FDA Complies
REMARKS: THE ABOVE PRODUCT OF THIS BATCH UNDER TEST CONFORMS TO CLAIM
AS PER PROCEDURE.