Betadex Sulfobutyl Ether Sodium

Betadex Sulfobutyl Ether Sodium 구조식 이미지
카스 번호:
182410-00-0
상품명:
Betadex Sulfobutyl Ether Sodium
동의어(영문):
SBE-β-CD;CAPTISOL;sodiuM salts;Sulfobutylether-β-Cyclodextrin;b-Cyclodextrin sulfobutyl ether sodium salt;β-Cyclodextrin, sulfobutyl ethers, sodium salts;SBEBCD;Sulfobutyl beta cyclodextrin;sulfobutyl ether B-cyclodextrin;Sulfobutyl Ether-beta-cyclodextrin Sodium Salt
CBNumber:
CB41208906
분자식:
C42H70O35
포뮬러 무게:
1134.9842
MOL 파일:
182410-00-0.mol
MSDS 파일:
SDS

Betadex Sulfobutyl Ether Sodium 속성

녹는점
202-204°C (dec.)
저장 조건
Inert atmosphere,Room Temperature
용해도
Soluble in water. Insoluble in acetone, methanol, chloroform.
물리적 상태
고체 분말
색상
흰색에서 황백색까지
InChIKey
WHGYBXFWUBPSRW-CQFZCEJCNA-N
안전
  • 위험 및 안전 성명
  • 위험 및 사전주의 사항 (GHS)
HS 번호 2940006000
그림문자(GHS):
신호 어: Warning
유해·위험 문구:
암호 유해·위험 문구 위험 등급 범주 신호 어 그림 문자 P- 코드
H317 알레르기성 피부 반응을 일으킬 수 있음 피부 과민성 물질 구분 1 경고 GHS hazard pictograms P261, P272, P280, P302+P352,P333+P313, P321, P363, P501
예방조치문구:
P261 분진·흄·가스·미스트·증기·...·스프레이의 흡입을 피하시오.
P272 작업장 밖으로 오염된 의복을 반출하지 마시오.
P280 보호장갑/보호의/보안경/안면보호구를 착용하시오.
P302+P352 피부에 묻으면 다량의 물로 씻으시오.
P321 (…) 처치를 하시오.
P333+P313 피부자극성 또는 홍반이 나타나면 의학적인 조치·조언를 구하시오.
P363 다시 사용전 오염된 의류는 세척하시오.
P501 ...에 내용물 / 용기를 폐기 하시오.

Betadex Sulfobutyl Ether Sodium C화학적 특성, 용도, 생산

화학적 성질

β-Cyclodextrin, sulfobutyl ethers, sodium salts is a cyclic oligosaccharide containing seven D-(t)- glucopyranose units attached by α(1→4) glucoside bonds. Sulfobutylether b-cyclodextrin is an anionic bcyclodextrin derivative with a sodium sulfonate salt separated from the hydrophobic cavity by a butyl spacer group. The substituent is introduced at positions 2, 3, and 6 in at least one of the glucopyranose units in the cyclodextrin structure. Introducing the sulfobutylether (SBE) into b-cyclodextrin can produce materials with different degrees of substitution, theoretically from 1 to 21; the hepta-substituted preparation (SBE7-b-CD) is the cyclodextrin with the most desirable drug carrier properties. Sulfobutylether b-cyclodextrin occurs as a white amorphous powder.

생산 방법

Sulfobutylether β-cyclodextrin is prepared by alkylation of bcyclodextrin using 1,4-butane sultone under basic conditions. The degree of substitution in b-cyclodextrin is controlled by the stoichiometric ratio of β-cyclodextrin to sultone used in the process.

Toxicity evaluation

Sulfobutylether b-cyclodextrin sodium (SBECD) has been associated with toxic effects in the kidney. Doses up to 1500 mg/kg produced no histopathological evidence of toxicity in dog kidneys.

Safety

Sulfobutylether b-cyclodextrin is derived from b-cyclodextrin, which is nephrotoxic when administered parenterally. However, studies have shown that sulfobutylether bcyclodextrin is well tolerated at high doses, when administered via intravenous bolus injections, orally, and by inhalation. Up to 9 g/day may be administered by IV infusion in a licensed voriconazole formulation. The safety following high doses of sulfobutylether β-cyclodextrin intravenous administration in humans is continually being investigated.
Sulfobutylether β-cyclodextrin has been subjected to an extensive battery of in vitro and in vivo genotoxicity and pharmacological evaluations. No genotoxic or mutagenic changes were observed with sulfobutylether β-cyclodextrin administration. Sulfobutylether β-cyclodextrin is biocompatible and exhibits no pharmacological activity. It is rapidly eliminated unmetabolized when administered intravenously.

저장

Sulfobutylether b-cyclodextrin(182410-00-0) is stable in the solid state and should be protected from high humidity. It should be stored in a tightly sealed container in a cool, dry place.
It will reversibly take up moisture without any effect on the appearance of the material at humidities up to 60% RH. Equilibration at RH values above 60% will result in deliquescence. Once in this state, the material can be dried, but will give a glasslike product. This water absorption behavior is typical of amorphous hygroscopic materials.
Sulfobutylether b-cyclodextrin is stable in aqueous solutions at values above about pH 1. It can degrade in highly acidic (pH < 1) solutions, particularly at elevated temperatures, producing the ring-opened form, followed by hydrolysis of the a(1-4) glucoside bonds.
Sulfobutylether b-cyclodextrin solutions may be autoclaved.

비 호환성

The preservative activity of benzalkonium chloride is reduced in the presence of sulfobutylether b-cyclodextrin.

Regulatory Status

Sulfobutylether β-cyclodextrin is included in IV and IM injectable products currently approved and marketed in the USA, Europe, and Japan. It is included in the FDA Inactive Ingredients Database for IM and IV use. Its use by other routes, including SC, oral, inhalation, nasal and ophthalmic, is being evaluated in clinical studies.

Betadex Sulfobutyl Ether Sodium 준비 용품 및 원자재

원자재

준비 용품


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