Hyaluronic Acid Quality Control Testing Service

Hyaluronic acid (HA), also known as sodium hyaluronate, is a high molecular weight linear polymer with repeating disaccharide units. Each disaccharide unit comprises a D-glucuronic acid and a N-acetyl-D-glucosamine residue linked by glycosidic bonds. HA is widely distributed in the human body, particularly in the eyes, synovial fluid, and skin. It is known for its unique molecular structure and physicochemical properties, displaying a variety of important physiological functions such as lubricating joint, regulating vascular permeability, modulating proteins, and promoting wound healing. Importantly, HA is recognized as the best natural moisturizing substance found in nature, termed as the ideal natural moisturizing factor (NMF). It enhances skin metabolism, making the skin soft, smooth, elastic, and anti-aging, and acts as a good transdermal absorption promoter while moisturizing.

 

Currently, HA is extensively used in the cosmetics industry, biomedical industry, etc., making accurate testing of HA-containing new products crucial for developing new injectable soft tissue fillers, wrinkle fill gels, cosmetics, and medical devices such as tissue scaffolds. HA is also used in ocular solutions, enteral medications, nasal sprays, aerosols, and is a key active ingredient in products aimed at preventing skin aging (such as viscous supplements). Understanding the quantity, purity, physicochemical properties, chemical composition, and microbiological characteristics of HA is essential for supporting its research and development, monitoring raw material quality, and the manufacturing process.

 

MtoZ Biolabs have developed and validated a unique and accurate analytical service based on multiple platforms like ICP-MS, ICP-AES, GC-MS, IC, etc., to control the quality of raw materials and finished products containing HA. Additionally, we provide method development and validation, stability studies under controlled temperature and humidity, and leachables and extractables studies. MtoZ Biolabs focuses on product quality and safety, helping clients meet and exceed the quality, safety, and regulatory standards for HA products. MtoZ Biolabs’ HA quality control testing includes the analysis of the following characteristics.

 

Services at MtoZ Biolabs

1. Appearance, Form and Color

2. HA Dosage/Concentration

3. BDDE (1,4-butanediol Diglycidyl Ether), Lidocaine Hydrochloride Content Determination

4. Structure Identification/Confirmation

5. Stability Determination

6. Organic Volatile Impurities and Particulates, Water Content, Protein Content, Residual Chemicals or Solvents, Degradation Products Determination

7. Physicochemical Properties, such as pH, Osmolarity, Viscosity, and Particle Size

8. Heavy Metals Analysis

9. Compatibility Testing

 

MtoZ Biolabs is committed to providing professional service like quality control testing and project validation for the bio/pharmaceutical and medical device industries. The laboratory complies with regulations and guidelines from NMPA, ICH, FDA, and EMA. With a complete quality system, cold/hot remote data backup, regular equipment calibration/interim checks, software audit tracking, we provide one-stop solutions and technical services to support bioproduct research and development, application registration, and production release. Our HA quality control testing platform, developed and validated, offers a range of chemical, biochemical, microbiological, and physicochemical testing services to assist you in quality control, ensuring the highest quality products that meet regulatory and consumer expectations for safety and efficacy.

 

FAQ

Q1: Why is HA analysis necessary in the medical industry?

HA is a common filler used in the medical industry for filling treatments and treating certain eye and joint conditions. Analyzing HA in the medical industry can:

(1) Check the quality and purity of the HA used in medical products;

(2) Assess the concentration of HA in medical products to ensure it meets required specifications;

(3) Understand the physical and chemical properties of HA: its viscosity, stability, and filling effect. All these properties optimize its use in medical products;

(4) Evaluate the effectiveness of different types of HA in treating specific diseases during formulation testing.

 

Thus, HA analysis helps medical manufacturers ensure their products meet quality and safety standards, optimize their formulations for best results, and evaluate their effectiveness in treating various conditions.

 

Q2: Why is HA analysis necessary in the cosmetics industry?

HA is a popular material in the cosmetics industry due to its moisturizing and anti-aging properties. The cosmetics industry must analyze HA to:

(1) Verify the quality and purity of the HA used in cosmetic formulations;

(2) Measure the concentration of HA in cosmetics to ensure it meets required specifications.

(3) Assess the effectiveness of different types of HA, including in formulation testing.

(4) Understand the physical and chemical properties of HA, such as its molecular weight or size distribution. Thus, the cosmetics industry can optimize its formulations in cosmetics.

 

In other words, HA analysis helps cosmetic manufacturers ensure their products contain the required active ingredients and optimize their formulations for best effects.