In the first quarter of 2021, 3 pharmaceutical excipients of our company turned into “A（active）” status through joint review with preparations. Our company newly registered 6 pharmaceutical excipients and 2 APIs that were already publicized on the CDE platform.
Excpients
1.Polysorbate 80（Tween 80 HP）
Polysorbate 80 was approved by CDE on February 1st and changed into “A” status with the registration number of F20170000268
· Origin: US
· Characteristics: In accordance with USP, EP, JP and ChP, low moisture and low peroxide value.
· Application: commonly used as O / W emulsifier, solubilizer and humectant
2.Sesame Oil SR
Sesame oil SR was approved by CDE on February 1st and changed into “A” status with the registration number of F20180001632
· Origin: US
· Characteristics: In accordance with USP, EP, JP and ChP. Croda adopted its unique super refined technology to purify sesame oil by removing polar impurities (such as primary and secondary oxidation products) in natural oil. Croda improves the color, odour and smell of the product without changing the form of basic triglyceride. It increases the stability of the preparation by reducing the adverse impact on APIs.
· Application: Sesame oil is an ideal solvent for oil-soluble sustained release injections like steroid, avermectin and etc. It can also be used in suspension, emulsion, ointment, ophthalmic preparation and suppository.
3.Macrogol Cetostearyl Ether
Macrogol Cetostearyl Ether was approved by CDE on January 7th and changed into “A” status with the registration number of F20180001324.
· Origin: Singapore
· Characteristics: In accordance with USP, EP
· Application: Macrogol Cetostearyl Ether is used as emulsifier in cream and emulsion. It is also used as solubilizer in essential oils, vitamin oils and low water-soluble drugs. It is relatively stable under moderate and strong acid and alkali conditions.
4.Diisopropyl Adipate
Diisopropyl Adipate was publicized on the CDE platform on March 17th with the status of “I” and its registration number is F2021000008
· Origin: Japan
· Characteristics: In accordance with JP; extremely low viscosity; good solubility and ductility.
· Application: It is recommended to be used as solvent or carrier for external preparation.
5.White Vaseline
White Vaseline was publicized on the CDE platform on March 17th with the status of “I” and its registration number is F2021000009
· Origin: Japane
· Characteristics: In accordance with JP, EP, JP, ChP. Croda adopted its unique super refined technology to remove the polar impurities in Vaseline, thus enhancing the stability of the preparation and reducing the potential skin irritation.
· Application: It is mainly used as moisturizing ointment base for topical administration drugs.
6.Medium-Chain Triglycerides
Medium-Chain Triglycerides was publicized on CDE platform on March 9th with the status of “I” and its registration number is F20210000028
· Origin: Singapore
· Characteristics: In accordance with USP, EP, ChP; good oxidation stability
· Application:&nb...
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