Medical Device Grade Sodium Hyaluronate

1. Sodium Hyaluronate Medical Device Grade Characteristics

CAS No.: 9067-32-7

Other names: HA medical device grade, hyaluronic acid medical device grade

Formula: (C14H20O11N1Na1)n

MOQ: 5g

Package: 5g/bag, 100g/bag, 100g/bottle

HS Code: 3913900090

Certificate: ISO/Kosher/Halal

Grade: Medical Device Grade

Appearance: White powder

Standard: EP11.0

Content: 95%-105.0%

2. Sodium Hyaluronate Medical Device Grade Specification

Across Biotech supplies sodium hyaluronate medical device grade powder used in human being implants, skin booster, medical aesthetic filling. artificial skin transplantation surgery, fast contact medical device, and etc.

 

There’re four types

Medical Device Injection Grade, for medical device of class Ⅲ and class Ⅱ

Medical Device M Grade, for medical device of class Ⅲ and class Ⅱ

Medical Device S Grade, for medical device of classⅡlike microneedle ( superficial epidermal injection) or vial

Medical Device T Grade, for external use, like in mask or Ampoule

Check sodium hyaluronate medical device injection grade specification below:

 

1 Appearance White or almost white powder or fibrous aggregate
2 Identification

A.     Infrared absorption

 

 

 

Reaction of sodium

 

The IR spectrum of the sample exhibits maxima at the same wavelength as that of Ph. Eur. Reference spectrum of sodium hyaluronate

Positive

3 Appearance of solution Clear and the absorbance is NMT 0.01 at 600 nm
4 Ph 5.0~8.5(0.5% solution)
5 Intrinsic viscosity Test value
6 Molecular weight Test value
7 Nucleic acids The absorbance is NMT 0.05 at 260 nm
8 Protein ≤0.05%
9 Chlorides ≤0.1%
10 Loss on drying ≤10%
11 Iron ≤20ppm
12 Heavy metals ≤10ppm
13 Residual solvents (Ethanol) ≤0.5%
14 Assay 95.0%-105.0%
15 Bacterial endotoxins <0.015IU/mg
16 Microbial contamination-TAMC ≤100CFU/g
17 Microbial contamination-TYMC ≤10CFU/g

 

3. Sodium Hyaluronate Medical Device Grade FAQs

3.1 For Sodium Hyaluronate Medical Device Grade, what is the MOQ?

5g is available.

 

3.2 Which type of sodium hyaluronate should we use, if our finished products are involved in CEP/DMF?

Then we recommend use pharma grade.

 

3.3 What is bacterial endotoxins range for the sodium hyaluronate medical device grade?

Normally, it’s <0.015IU/mg, <0.05IU/mg, and 0.5IU/mg. But we’re able to provide <0.005IU/mg and customized.

 

 

4. About Sodium Hyaluronate Medical Device Grade Supplier

Across Biotech Jinan Co., Ltd is a reliable hyaluronic acid medical device grade powder supplier in China, CAS No. 9067-32-7, exporting food/feed/technical grade to food manufacturers, additives and ingredients wholesalers and distributors abroad at attractive prices. Please reach us at sales@acrossbiotech.com for more info.

 

5. Documents about Sodium Hyaluronate Medical Device Grade

COA Sodium Hyaluronate Medical Device Injection Grade

COA Sodium Hyaluronate Medical Device M Grade

☞ Check our inventory

ikea, warehouse, industrial-2714998.jpg

Inventory Updated 2022.5.20

1. Flavorings Items Quantity Vanillin (Julan Brand) 2,000 kgs Vanillin (Eternal Pearl Brand) 8,000 kgs 2. Preservatives Items Quantity Natamycin 50% in lactose 650 kgs

Read More »

Contact Info

Address​

Shanda Rd 160, Lixia distric, Jinan, China

Working Hours

Monday-Friday: 9:00-18:00

We're Ready, Let's Talk.