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순도시험
(1) 비소 : 이 품목을 비소시험법에 따라 시험할 때, 그 양은 2.0ppm 이하이어야 한다.
(2) 납 : 이 품목 5.0g을 취하여 원자흡광광도법 또는 유도결합플라즈마발광광도법에 따라 시험할 때, 그 양은 3.0ppm 이하이어야 한다.
(3) 융점 : 융점측정법에 따라 시험할 때, 표시온도(48～93℃) 범위이어야 한다.
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확인시험
적외부 흡광분광광도계로 스펙트럼을 측정할 때, 다음의 스펙트럼의 특성을 나타낸다. 검체는 녹여 브롬화칼륨판을 사용하여 측정한다.
(1) 정제석유왁스
(2) 마이크로크리스탈린왁스
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정의
이 품목은 원유의 감압증류 잔사유를 차가울 때 프로판으로 탈레이크, 탈납, 탈유한 다음 분리하여 얻어지는 것이나 또는 뜨거울 때 푸르푸랄로 처리한 다음 푸르푸랄을 제거하여 얻어지는 것으로서 그 성분은 C30～C60의 분지탄화수소를 함유한다.
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화학적 성질
Microcrystalline wax occurs as odorless and tasteless waxy lumps
or flakes containing small irregularly shaped crystals. It may vary in
color from white to yellow, amber, brown, or black depending on
the grade of material; pharmaceutical grades are usually white or
yellow.
The USP32–NF27 describes microcrystalline wax as a mixture
of straight-chain, branched-chain, and cyclic hydrocarbons,
obtained by solvent fractionation of the still-bottom fraction of
petroleum by suitable means of dewaxing or de-oiling.
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생산 방법
Microcrystalline wax is obtained by solvent fractionation of the
still-bottom fraction of petroleum by suitable dewaxing or deoiling.
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Pharmaceutical Applications
Microcrystalline wax is used mainly as a stiffening agent in topical
creams and ointments.
The wax is used to modify the crystal structure of other waxes
(particularly paraffin wax) present in a mixture so that changes in crystal structure, usually exhibited over a period of time, do not
occur. Microcrystalline wax also minimizes the sweating or bleeding
of oils from blends of oils and waxes. Microcrystalline wax
generally has a higher melting point than paraffin wax, and higher
viscosity when molten, thereby increasing the consistency of creams
and ointments when incorporated into such formulations.
Microcrystalline wax is also used in oral controlled-release
matrix pellet formulations for various active compounds and as
a tablet- and capsule-coating agent. In controlled-release systems,
microcrystalline wax coatings can also be used to affect the release
of drug from ion-exchange resin beads.
Microcrystalline wax is also used in confectionery, cosmetics,
and food products.
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Safety
Microcrystalline wax is mainly used in topical pharmaceutical
formulations but is also used in some oral products. It is generally
regarded as a nontoxic and nonirritating material.
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저장
Microcrystalline wax is stable in the presence of acids, alkalis, light,
and air. The bulk material should be stored in a well-closed
container in a cool, dry place.
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Regulatory Status
GRAS listed. Accepted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (oral capsules;
topical and vaginal preparations). Included in nonparenteral
medicines licensed in the UK. Included in the Canadian List of
Acceptable Non-medicinal Ingredients.
