AVT (Shanghai) Pharmaceutical Tech Co., Ltd

The company's products range from high quality traditional injection grade phospholipid excipients applied for liposomes and fat emulsions, such as natural phospholipids, HSPC, DSPE-PEG2000, CHO, etc.; as well as protective agents and buffers salts used in vaccines, antibody proteins, antibody-conjugated drugs and other biological formulations, such as trehalose, sucrose, sucrose potassium octasulfate, etc. https://www.avt-pharma.com/

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AUXILIARY EMULSIFIER (FOR FAT EMULSION)

Auxiliary emulsifier (for fat emulsion) include Oleic Acid Cas No.: 112080-1. High purity, Low impurities, Production in accordance with GMP

In some cases, the use of single emulsifier cannot meet the quality requirements, so it is necessary to use oleic acid or sodium oleate as an auxiliary emulsifier. Auxiliary emulsifying agents stabilize the emulsion by acting as thichening agents to stabilize emulsion.

TYPES OF AUXILIARY EMULSIFIER (FOR FAT EMULSION)

Oleic Acid Cas No.: 112080-1

Oleic acid can be used as co-emulsifier in lipid emulsions to improve the emulsification effect and enhance the stability of the emulsion.

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THE EFFECTS OF AUXILIARY EMULSIFIER (FOR FAT EMULSION)

01

Oleic acid is used as a co-emulsifier in emulsion preparations to improve the emulsification effect and enhance emulsion stability.

02

The emulsifier is a mixture of polyssorbitol 80 with mono glycerol and diglycerol, 40% α -mono glycerol, 70% α -mono glycerol and lecithin. Samples containing lecithin had the lowest flavor scores.

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D(+)-TREHALOSE DIHYDRATE (FOR INJECTION) CAS NO.: 6138-23-4

AVT offers crystalline trehalose dihydrate (for injection) cas no.6138-23-4 with product quality in line with trehalose dihydrate GMP, treha

CAS No.: 6138 23 4

D(+)-TREHALOSE DIHYDRATE (FOR INJECTION) CAS NO.: 6138-23-4

AVT trehalose dihydrate (for injection) is commonly used in lyophilized protective agent, lipid nanoparticles and mRNA stabilizer and cryoprotectant. Highly cost-effective, Injection grade, product quality in line with ChP, USP, JP, EP standards,CAS NO.: 6138-23-4. Registered with the US FDA, DMF No.034401 and 035566.

D(+)-TREHALOSE DIHYDRATE (FOR INJECTION) KEY BENEFITS

AVT introduces the specifications of trehalose dihydrate like trehalose dihydrate molecular weight. It also can called alpha alpha trehalose dihydrate and crystalline trehalose dihydrate has many benefits.

Highly cost-effective, low endotoxin (<0.1IU/g), injection grade.

Comply with the national pharmacopeia standards, ChP, JP, EP, and our trehalose dihydrate also meet USP and GMP standards.

D(+)-TREHALOSE DIHYDRATE (FOR INJECTION) SPECIFICATIONS

Product Name:

D(+)-Trehalose dihydrate (for injection)

Chemical Name:

α-D-glucopyranosyl-α-D-glucopyranoside dihydrate

Content Determination:

0.993

CAS No.

6138-23-4

FDA DMF No.

DMF No. 034401

Molecular Formula:

C12H22O11·2H2O

Molecular Weight:

378.33

Properties:

crystalline powder

Specific Rotation:

+198.8°

Acidity:

6

Chloride:

the regulations

Sulfate:

the regulations

Soluble Starch:

in line with regulations

Residue on Ignition:

ignition: 0.04%

Heavy Metals:

in compliance with regulations

Moisture:

9.50%

Related Substances:

total impurities 0.06%, glucose not detected, maltotriose 0.06%, the largest unknown single impurities not detected

Microbial Limit:

sterile

Bacterial Endotoxin:

<0.1IU/g

Nitrogen:

line with regulations

Determination of Content:

99.30%

Solubility:

soluble in water, soluble in hot ethanol, slightly soluble in methanol, insoluble in ether and acetone

Storage:

stored in a cool, dark, and dry place, and transported at room temperature

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SUCROSE (FOR INJECTION) CAS NO.: 57-50-1

AVT brand intramuscular formulation is injectable grade sucrose of high purity and low endotoxin, which is often used in the pharmactutical

SUCROSE (FOR INJECTION) CAS NO.: 57-50-1

It not only acts as a cryopreservative in the lyophilization process, but also acts as a dehydration protectant in drying and dehydration, and can also adjust the osmotic pressure. Sucrose is recognized as one of the most widely used and most effective lyoprotectants.

SPECIFICATIONS OF SUCROSE (FOR INJECTION)

Product Name

Sucrose (for injection)

Chemical Name

α-D-Glucopyranoside, β-D-fructofuranosyl-sucrose

CAS No.

57-50-1

EINECS Registration Number

200-334-9

CDE Record Registration Number

F20200000093

FDA DMF Number

35209

Grade

Pharmaceutical injection grade

Quality Standards

in line with national pharmacopeia standards (Chp, USP, JP, EP)

Molecular Formula

C12H22O11

Molecular Weight

342.3

Product Code

O09001

Available Package Sizes

10kg,25kg

KEY BENEFITS OF SUCROSE (FOR INJECTION)

FDA DMF NumberDMF: 35209; CDE Record registration Number:F20200000093.

Aseptic GMP production environment, low endotoxin (<0.5IU/g), injection grade.

Can be used for antibodies, liposomes, vaccines and other biologics (e.g. mRNA-1273®, BNT162b2®, Enbrel®).

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CHOLESTEROL HP CAS NO.: 57-88-5

AVT Cholesterol (for injection), Cholest-5-en-3β-ol, C27H46O, DMF number: 024780, EINECS number: 200-353-2, CDE registration number: F201700

CHOLESTEROL HP CAS NO.: 57-88-5

AVT's high-purity cholesterol CHO HP CAS NO.: 57-88-5 is obtained from lanolin after extraction, hydrogenation, and refining. The final purity can reach 99% at least. CHO HP is the specific parenteral excipient for liposomes. Cholesterol HP can enhance the stability of liposome membranes and reduce drug leakage. It can also improve the ability of liposome vesicles to resist changes in external conditions.

CHOLESTEROL HP CAS NO.: 57-88-5 SPECIFICATIONS

Product Name

Cholesterol (for injection)

Chemical Name

Cholest-5-en-3β-ol

CAS No.

57-88-5

EINECS Registration Number

200-353-2

CDE Record Registration Number

F20170000106

FDA DMF Number

24780

Grade

Pharmaceutical injection grade

Quality Standards

in line with national pharmacopeia standards (Chp, USP, JP, EP)

Molecular Formula

C27H46O

Molecular Weight

386.7

Product Code

O01001

Available Package Sizes

10kg

CHOLESTEROL HP CAS NO.: 57-88-5 KEY BENEFITS

CHO HP is a high-purity parenteral pharmaceutical excipient produced in accordance with GMP guidelines. US DMF number is 024780, NMPA registration number is F20170000106.

Different from the animal tissue extraction method commonly used in domestic to produce cholesterol, CHO HP is made from lanolin with semi-synthetic method.

The product purity is high (NLT 99%), and there will be no virus contamination of animal tissues. It has been used in multiple marketed liposome products internationally for a long time.

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CHOLESTEROL (FOR LIPOSOMES)

HSPC/Hydrogenated Soy Phosphatidylcholine Cas No.: 92128-87-5. Synthetic phospholipids mainly include DPPC, DPPE, DSPC, etc., which are all

AVT's high-purity liposome cholesterol CHO HP is obtained from lanolin after extraction, hydrogenation, and refining. The final purity can reach 99% at least. It is the specific parenteral excipient for liposomes.

TYPES OF CHOLESTEROL IN LIPOSOMES

Cholesterol HP Cas No.: 57-88-5

1. Trade name: CHO-HP; 2. Name: Cholesterol (for injection); 3. Chemical name: Cholest-5-en-3β-ol; 4. Molecular formula: C27H46O; 5. CAS number: 57-88-5; 6. DMF number: 024780; 7. EINECS number: 200-353-2; 8. CDE registration number: F20170000106; 9. Grade: pharmaceutical injectable grade; 10. Quality standards: USP, EP, CP; 11. Cholesterol is added in liposomal formulation mixture for following purpose (Usages): liposome membrane material, emulsifier; 12. Solubility: easily soluble in methanol, ethanol and chloroform, insoluble in water; 13. Molecular weight: 386.7; 14. Storage conditions: Room temperature; 15. Precautions: avoid strong acid, strong alkali and strong oxidizing substances.

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ROLES OF CHOLESTEROL IN LIPOSOMES

01

CHO HP is the specific parenteral excipient for liposomes.

02

It can enhance the stability of liposome membranes and reduce drug leakage.

03

It can also improve the ability of liposome vesicles to resist changes in external conditions.

HOW DO CHOLESTEROL (FOR LIPOSOMES) WORK?

How do Cholesterol (For Liposomes) Work?

1. CHO HP is a high-purity parenteral pharmaceutical excipient produced in accordance with GMP guidelines. US DMF number is 024780, NMPA registration number is F20170000106.

2 Different from the animal tissue extraction method commonly used in domestic to produce cholesterol, CHO HP is made from lanolin with semi-synthetic method.

3. The product purity is high (NLT 99%), and there will be no virus contamination of animal tissues. It has been used in multiple marketed liposome products internationally for a long time.

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BUFFER SALTS (FOR BIOLOGICAL)

AVT has newly launched tromethamine (TRIS), the buffer salts used in biomedicine and it is in registration progress of NMPA and US FDA. The

Buffer salts (for Biological) belong to biological buffer systems, which contain dozens of varieties like buffered electrolyte salts.

Tris, HEPES are among the typical varieties.

Tris is a buffered salt widely used in the field of biomedicine. Buffered Salt is a combination mineral supplement that may be helpful in reducing tiredness.

AVT has newly launched tromethamine (TRIS), which is in the process of NMPA and US FDA registration.

The product advantages including high purity, low impurities, production in accordance with GMP guideline, stable supply and high cost-effective.

TYPES OF BUFFERED SALT (FOR BIOLOGICAL)

Tromethamine Tris Buffer Cas No.: 77-86-1

Tromethamine Tris: 1. English name: Tris Base; 2. Chemical name: Tris(hydroxymethyl)aminomethane; 3. Trade name: Tris; 4. Molecular formula: C4H11NO3; 5. CAS: 77-86-1; 6. Grade: chemical reagent grade; 7. Properties: This product is white crystal; 8. Purity: >99% (see COA for details); 9. Solubility: water 550 g/L (25℃); 10. Molecular weight: 121.14; 11. Melting point: 167-172℃; 12. Boiling point: 219-220℃ 10 mm Hg.

HEPES

Tris-HCl

BUFFERED SALT (FOR BIOLOGICAL) EFFECTS

01

Tromethamine (Tris) is a buffer salt widely used in the field of biomedicine. Chemical formula is C4H11NO3. It is white crystalline particles, commonly used in protein or nucleic acid buffers. The effective range is usually between pH 7.0-9.2.

02

Tris is used for the growth of protein crystals under different pH conditions. Tris is also one of the main components of protein electrophoresis buffer. It forms a buffer system with glycine in the electrophoresis buffer to stabilize the pH during electrophoresis.

03

In addition, Tris is also an intermediate in the preparation of surfactants, vulcanization accelerators and some drugs. Titration standard substance is also its usage.

HOW DO BUFFER SALTS (FOR BIOLOGICAL) WORK?

How do Buffer Salts (for Biological) Work?

1. The basicity of Tris base is strong, so we can use only this buffer system to prepare buffers with a wide range of pH ranging from acidic to basic. The application range is wide.

2. Tris buffer has little interference with biochemical processes and does not precipitate with calcium, magnesium ions and heavy metal ions.

3. Tris is highly soluble in water and is inert to many enzyme reactions.

4. Tris has high buffering capacity, especially between pH 7.5-9.0.

5. Tris buffer is widely used and plays an important role in biochemistry, molecular biology, in vitro diagnosis, cosmetics, coatings and other fields.

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BIOPHARMACEUTICAL EXCIPIENTS

AVT biologic excipients are registrered in NMPA. We have sufficient production capacity with annual excipients in biologics output around 50

Our biopharmaceutical excipients production base is in China, which complies with China's regulatory requirements for biopharmaceutical excipients market. The biologic excipients are also registrered in NMPA. We have sufficient production capacity with annual output around 50 to 300 tons to meet supply needs of biologic excipients market.

BIOPHARMACEUTICAL EXCIPIENTS FOR SALE

Protective Agents (For Biological)

> D(+)-Trehalose Dihydrate (For Injection) CAS No.: 6138-23-4

> D(+)-Trehalose Dihydrate (For Injection)(Sterile) Cas No.: 6138-23-4 For Sale

> Cas No.: 57-50-1 Sucrose For Sale (For Injection)

Biological protective agent: sugar is the most common and widely used type of cryoprotectants. AS a non-specific stabilizer of protein, it can stabilize protein throughout the various stages of lyophilization.

Buffer Salts (For Biological)

> Tromethamine Tris Buffer Cas No.: 77-86-1

> HEPES

> Tris-HCl

Biological buffer salts: commonly used for proteins or nucleic acids, pH buffers.

BIOPHARMACEUTICAL EXCIPIENTS BENEFITS

Biopharmaceutical Excipients Benefits

Trehalose has stronger hydration ability, higher glass transition temperature, and resistance to high temperature and humidity.

Excipients used in biologics can effectively improve the quality and manufacturing efficiency of biological products.

Improve the stability of pharmaceutical products.

Improve the stability of protein.

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PHARMACEUTICAL EXCIPIENTS IN AVT

AVT pharmaceutical excipients are widely used in marketed liposomes, fat emulsion formulations and biological formulations as well as in the

Pharma excipients manufacturer AVT has been cultivating the market of high- end complex injection in China for more than ten years, and has been cooperating with domestic R&D and production companies, universities as well as research institutes on various types of complex injection for many years. Our injectable excipients are widely used in marketed liposomes, fat emulsion formulations and biological formulations as well as in the research and development of these new drugs. As a reliable pharma excipients supplier, the quality and safety of our various types of  pharmaceutical excipients are trustworthy.

TYPES OF PHARMACEUTICAL EXCIPIENTS

Biopharmaceutical Excipients

> Protective Agents (For Biological)

> Buffer Salts (For Biological)

01

Biopharmaceutical Excipients

AVT strives to provide low-endotoxin excipients used in injections that meet urgent needs of biopharmaceutical development. The quality of different types of excipients in pharma conforms to USP, EP, JP standards, and has been registered in US FDA with DMF number.

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Liposome Excipients

> Liposomal Phospholipids

> Cholesterol (For Liposomes)

> Protective Agents (For Liposomes)

> Sucrose Octasulfate Salt (For Liposomes)

02

Liposome Excipients

As pharma excipients manufacturer, we provide multi-species, injectable and high-purity for lipo-some drug development; our production base meets GMP requirements for pharma excipients market and can receive audits from various countries; we have a complete range of liposome excipients to meet the needs of different customers for types of excipients used in pharmaceutical industry and can provide customized pharmaceutically acceptable excipient services.

Fat Emulsion Excipients

> Phospholipids (For Fat Emulsion)

> Auxiliary Emulsifier (For Fat Emulsion)

03

Fat Emulsion Excipients

We provide cost-effective lecithins and oleic acid excipients for the devel-opment and production of fat emulsion drugs; The production base meets GMP requirements for excipient manufacturing; product quality complies with USP, EP and JP stan-dards, all excipients are injectable excipients; We have suficient production capacity with annual output of types of excipients around 50 to 300 tons to meet your demands.

Lipid nanoparticles（LNPs）

> Dlin-MC3-DMA

> SM-102

> ALC-0315

> DOTAP

> DC-CHOL

> DSPC

> DOPC

> DMG-PEG2000

04

Lipid nanoparticles（LNPs）

lipid nanoparticles (LNPs), are nanoparticles composed of lipids (including cationic lipid、phospholipid、PEG-lipid and helper lipid). They are the most clinically advanced non-viral gene delivery system for Intracellular Delivery of Nucleic Acid Therapeutics. LNPs as a drug delivery vehicle were first approved in 2018 for the siRNA drug Onpattro. Currently in the spotlight as vital components of the COVID-19 mRNA vaccines (including both the Moderna and the Pfizer–BioNTech COVID-19 vaccines), LNPs play a key role in effectively protecting and transporting mRNA to cells.

WHAT IS EXCIPIENTS MEANING IN PHARMACEUTICALS ?

In pharma excipients market, excipients in pharmacy refer to any kind of API (Active Pharmaceutical Ingredients) to be provided for clinical use, and must be made into various pharmaceutical preparations without dosage forms. In addition to the preparation of pharmaceutical preparations, some excipients that help the preparation of different functions such as molding, stabilization, increase solubility, and sustained release must also be added. These various necessities used in the manufacture and preparation of pharmaceutical preparations are called pharmaceutical preparation excipients, referred to as pharmaceutical excipients. The above is a brief introduction of the pharmaceutical excipients definition. Pharmaceutical excipients are the material basis for the existence of pharmaceutical preparations, and there is no pharmaceutical preparation without pharmaceutical excipients.