ISOPROPYL PALMITATE
화장품에서 아이소프로필팔미테이트 (ISOPROPYL PALMITATE)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?
아이소프로필팔미테이트(표준 INCI: ISOPROPYL PALMITATE, CAS 번호: 142-91-6)은 화장품 처방에서 주로 향료, 결합제, 에모리엔트 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 2–30%(적정 pH 4–8) 범위에서 안정적으로 처방됩니다.
7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스
각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건| 국가·규제 트랙 | 공식 고시 전성분 표기명 | 원클릭 복사 |
|---|---|---|
| ① 한국 (MFDS 화장품 한글 표준명) | 아이소프로필팔미테이트 | |
| ② 한국 구명칭 (개정 전 이력 · 301 리다이렉트) | 이소프로필팔미테이트 | |
| ③ 유럽 (EU CosIng EC 1223/2009) | ISOPROPYL PALMITATE | |
| ④ 미국 일반화장품 (US PCPC / MoCRA INCI) | ISOPROPYL PALMITATE | |
| ⑤ 미국 OTC (FDA Active Ingredient Monograph) | — (비-OTC 일반 화장품 원료) | — |
| ⑥ 중국 (NMPA IECIC 표준 중문명) | 棕榈酸异丙酯 | |
| ⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW) | ISOPROPYL PALMITATE (표준 INCI 기준 · 임의 가타카나 변환 배제) |
Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태
| 권역 | 규제 상태 | 배합 한도 | 제한 조건 및 1차 법원 출처 |
|---|---|---|---|
| 한국 (MFDS) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 유럽 (CosIng) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 미국 (FDA/CIR) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 중국 (NMPA) | 등재·허용 | GMP | IECIC Entry #8718 |
| 일본 (MHLW) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 아세안 (ACD) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조
Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드
| 제형군 분류 | Min – Q1 – Median – Q3 – Max (%) | 처방 역할 및 기전 | Source ID |
|---|---|---|---|
| 제형군 E — 무수 오일 · 멀티밤 · 립케어 | 2% · 4% · 5% · 8% · 30% | 무수 밤·스틱·오일 처방 유상 골격 및 보습막 형성 | Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 5 · ELEMENTIS 1 · GRANT 1) |
| 제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O) | 0.4% · 4% · 4.85% · 7% · 12% | 유화 로션·크림 제형 구조 형성 및 피부 컨디셔닝 | Global Starter Formulation Library Statistical Distribution (n=28, EVONIK 28) |
| 제형군 D — 자외선차단제(선크림) · 색조 · 파운데이션 | 2% · 2% · 3% · 7% · 7% | 선케어·색조 메이크업 분산 안정화 및 발림성 조절 | Global Starter Formulation Library Statistical Distribution (n=5, EVONIK 4 · GRANT 1) |
각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션
단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.
pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동
권장 구간 밖(pH < 4 또는 pH > 8)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.
최대 50°C 가열 공정에서 열적 안정성이 유지됩니다.
세포·분자 타깃 작용 기전 플로우 다이어그램
권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도
🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.
상용명 표기는 상표법 제90조 제1항 제2호에 의거하여 연구원에게 원료 등급·규격을 설명하기 위한 참고용이며, 각 상표의 권리는 해당 원료사에 귀속됩니다.
학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)
Tier 1 Synthesis이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.
근거 동료심사 학술 논문 (미국 NIH PubMed) (4)
Comparative evaluation of skin moisture after topical application of 10% and 30% lactobionic acid. [PMID: 29318715 · 2018]
Dry skin is characterized by symptoms such as itching, redness, excessive exfoliation. These symptoms cause discomfort and contribute to secondary bacterial infections. Dry skin treatments are based on topical applications of various formulations. Among many of them are polyhydroxy acids, which recently gained more attention. The aim of this study was a comparative assessment of hydration level (corneometric) after application of lactobionic acid (LA) in the form of peel at concentrations of 10% and 30%. The study involved 10 Caucasian individuals aged 26-73 years. Eight treatments were performed at weekly intervals. The peels were applied using the "Split face" method-on the left side of the face 10% LA, and the right side 30% LA which consisted of specified concentration of LA, deionized water, xanthan gum, ethoxydiglycol. The test subjects received a 5% LA cream for overnight use. The cream consisted of deionized water, LA, isopropyl palmitate, ascorbyl palmitate, methylparaben. The products for this study were provided by Grehen Ltd. Celestynów, Poland. Prior to each procedure, the skin hydration level was measured using Corneometer CM 825 from Courage + Khazaka electronic GmbH. There was a statistically significant improvement in hydration level after 8 treatments for all measuring points and both concentrations. The difference of the skin hydration level between 10% LA and 30% LA could not be determined. Lactobionic acid is a highly moisturizing agent. There was no significant difference in moisturizing effect between 10% LA concentration and 30% LA concentration.
Determination and confirmation of isopropyl p-toluenesulfonate in cosmetics by HPLC-diode array detector method and GC-MS. [PMID: 27169828 · 2016]
Isopropyl p-toluenesulfonate (IPTS) is a potentially genotoxic by-product formed during the esterification of palm oil-based palmitic and palm kernel oil-based myristic acid with isopropanol to produce isopropyl palmitate or isopropyl myristate. There are no methods described for the analysis of IPTS in cosmetic products. In this work, we have established a simple, precise and accurate method to determine the presence and level of IPTS in various finished cosmetic products which contain palm-based esters in their formulations. An Agilent 1200 series high-performance liquid chromatography (HPLC) unit using a diode-array detector (DAD) has been employed and optimized to detect IPTS in cosmetic products. For the separation, a reverse-phase Hypersil Gold C8 column (5 μm, 4.6 mm i.d. 250 mm) 5 mM tetrabutylammonium phosphate buffer 50 : 50, (v/v) solution in acetonitrile as mobile phase, in isocratic mode and a flow rate of 0.8 mL min -1 were used. A second method using a gas chromatography/mass selective detector GC-MSD was also developed to confirm the IPTS identity in the cosmetic products. Recoveries of IPTS from cosmetic matrices such as a lotion, cleansing milk and a cream ranged from 94.0% to 101.1% with <5% relative standard deviation (%RSD) showing good accuracy and repeatability of the method. The six-point calibration curves (determined over the range 0.5-50 μg mL -1 ) have a correlation coefficient of 0.9999 (based on HPLC peak area) and 0.9998 (based on HPLC peak height). The intra- and interday precisions (measured by the %RSD) of the method were <2% and <5%, respectively, indicating that the developed method is reliable, precise and reproducible. The detection and quantification limit of the method were found to be 0.5 μg mL -1 and 1.6 μg mL -1 , respectively. Analyses of 83 commercial cosmetics showed no presence of IPTS. The validation data indicated that this method was suitable for the quantitative analysis of IPTS in commercial cosmetics. This method is applicable for analyses of trace levels of IPTS in cosmetics and has the advantage of using only simple sample preparation steps.
Preparation and In Vitro Evaluation of W/O Nanoemulsions for the Skin Permeation of 5-Aminolevulinic Acid. [PMID: 36878583 · 2023]
We investigated the skin permeation of 5-aminolevulinic acid (ALA) through Yucatan micropig full-thickness skin by using ALA-loaded W/O nanoemulsions composed of Span/Tween/ethanol (EtOH)/isopropyl palmitate (IPP)/10 wt% aqueous ALA solution. The nanoemulsions were prepared using Span 20/Tween 20 (S20/T20), Span 80/Tween 80 (S80/T80), and Span 20/Tween 80 (S20/T80) mixed surfactant systems. Based on the results of the phase diagram study and hydrodynamic diameter measurement of the nanoemulsions, we decided that the optimal weight ratio of Span/Tween/EtOH/IPP/10 wt% aqueous ALA solution in the nanoemulsion was 0.8/0.2/14/19/1.4. The permeability coefficient of ALA in the S20/T80 system was approximately five times larger than those in the S20/T20 and S80/T80 systems. The high skin permeation of ALA afforded by the ALA-loaded W/O nanoemulsion in the S20/T80 system is attributable to a significant enhancement in the partitioning of ALA to the stratum corneum.
Percutaneous Absorption of Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol from ABH Gel. [PMID: 32196480 · 2020]
The objective of this project was to study the percutaneous absorption of lorazepam, diphenhydramine hydrochloride, and haloperidol from a topical Pluronic lecithin organogel, also known as ABH gel, across the porcine ear skin and verify its suitability for topical application. ABH gel was prepared using lecithin in isopropyl palmitate solution (1:1) as an oil phase and 20% w/v Poloxamer 407 solution as an aqueous phase. The gel was characterized for pH, viscosity, drug content, and thermal behavior. A robust high-performance liquid chromatography method was developed and validated for simultaneous analysis of lorazepam, diphenhydramine hydrochloride, and haloperidol. The percutaneous absorption of lorazepam, diphenhydramine hydrochloride, and haloperidol from ABH gel was carried out using Franz cells across the Strat-M membrane and pig ear skin. The pH of ABH gel was found to be 5.66 ± 0.13. The retention time of diphenhydramine hydrochloride, haloperidol, and lorazepam was found to be 5.2 minutes, 7.8 minutes, and 18.9 minutes, respectively. The ABH gel was found to be stable for up to 30 days. Theoretical steady state plasma concentrations (CSS) of diphenhydramine hydrochloride, haloperidol, and lorazepam calculated from flux values were found to be 1.6 ng/mL, 0.13 ng/mL, and 2.30 ng/mL, respectively. The theoretical CSS of diphenhydramine hydrochloride, haloperidol, and lorazepam were much lower than required therapeutic concentrations for antiemetic activity to relieve chemotherapy-induced nausea and vomiting. From the percutaneous absorption data, it was evident that ABH gel failed to achieve required systemic levels of lorazepam, diphenhydramine hydrochloride, and haloperidol following topical application.
자주 묻는 질문 (AEO 스니펫 최적화 FAQ)
- Q1. 아이소프로필팔미테이트 (ISOPROPYL PALMITATE)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
- 한국 식약처 표준명은 '아이소프로필팔미테이트', 미국 PCPC 및 유럽 CosIng INCI 표기는 'ISOPROPYL PALMITATE', 중국 NMPA IECIC 표준명은 '棕榈酸异丙酯', 일본 화장품 표시명칭은 'ISOPROPYL PALMITATE'입니다.
- Q2. 아이소프로필팔미테이트의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
- 한국(KR: none), 유럽(EU: none), 미국(US: none), 중국(CN: allowed), 일본(JP: none), 아세안(ASEAN: none) 고시 기준을 준수하여 처방해야 합니다.
- Q3. 제형 설계 시 아이소프로필팔미테이트의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
- 대표 제형군(anhydrous_balm) 기준 통상 2~30%(권장 중앙값 5%) 범위로 투입하며, 적정 pH는 4~8입니다.
- Q4. 아이소프로필팔미테이트 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
- 주요 권장 시너지 조합은 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL이며, 배합 주의사항은 처방 내 극단적 pH 조건 및 고농도 전해질과의 상용성 사전 확인 권장입니다.