ISOPROPYL PALMITATE
化妆品中 棕榈酸异丙酯 (ISOPROPYL PALMITATE) 的全球法规限值与配方应用标准是什么?
棕榈酸异丙酯(标准 INCI: ISOPROPYL PALMITATE,CAS 号: 142-91-6)是化妆品配方中主要用作香精 / 香料, 粘合剂, 柔润剂的核心成分。受中国 NMPA(已使用/准用)、韩国 MFDS(未列管)及欧盟 CosIng(未列管)等 6 大法域法定标准监管,常规建议添加量为 2–30%(最佳稳定窗口 pH 4–8)。
全球 7 轨官方全成分标签名称对照表
严格采用各国政府官方目录原名 · 严禁机器翻译| 法域与监管轨道 | 官方公告全成分标准名称 | 一键复制 |
|---|---|---|
| ① 韩国 (MFDS 化妆品标准名称) | ISOPROPYL PALMITATE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | Former KR Nomenclature Redirect Active | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | ISOPROPYL PALMITATE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | ISOPROPYL PALMITATE | |
| ⑤ 美国 OTC 防晒/祛痘专论活性物名称 (FDA OTC) | — (非美国 OTC 专论活性成分 / 普通化妆品原料) | — |
| ⑥ 中国 (NMPA《已使用化妆品原料目录 IECIC》标准中文名) | 棕榈酸异丙酯 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | ISOPROPYL PALMITATE (标准 INCI 参照) |
Layer 1 — 全球 6 大法域法定限值与监管状态
| 法域 | 监管状态 | 法定限值 | 适用条件与法定依据来源 |
|---|---|---|---|
| 韩国 (MFDS) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 欧盟 (EU) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 美国 (FDA) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 中国 (NMPA) | 已使用/准用 | GMP | IECIC Entry #8718 |
| 日本 (MHLW) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 东盟 (ACD) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — 剂型常规配比指南与理化配伍性
| 剂型分类 | Min – Q1 – Median – Q3 – Max (%) | 配方作用与机理 | Source ID |
|---|---|---|---|
| 剂型组 E — 无水精油 / 固体膏霜 / 唇部护理 | 2% · 4% · 5% · 8% · 30% | Anhydrous balm, oil & stick structural emollient | Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 5 · ELEMENTIS 1 · GRANT 1) |
| 剂型组 B — 乳液 / 面霜 (O/W · W/O) | 0.4% · 4% · 4.85% · 7% · 12% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=28, EVONIK 28) |
| 剂型组 D — 防晒霜 / 彩妆 / 粉底 | 2% · 2% · 3% · 7% · 7% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=5, EVONIK 4 · GRANT 1) |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
商品名仅供配方师识别原料规格参考,商标权归各原厂商所有。
学术与毒理综合摘要
Tier 1 Synthesis本综述严格基于与该原料关联的 NIH PubMed 同行评审文献摘要及官方毒理学评估档案编写。
关联同行评审文献 (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.
常见问题解答 (FAQ)
- Q1. 棕榈酸异丙酯 (ISOPROPYL PALMITATE) 在全球 7 大法域的官方全成分标签名称是什么?
- 中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名为 '棕榈酸异丙酯',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'ISOPROPYL PALMITATE',日本 JCIA 表示名称为 'ISOPROPYL PALMITATE'。
- Q2. 棕榈酸异丙酯 (ISOPROPYL PALMITATE) 在中、韩、欧、美、日、东盟的法定监管状态 (Layer 1) 如何?
- 6 大法域监管汇总 — 中国(CN): allowed,韩国(KR): none,欧盟(EU): none,美国(US): none,日本(JP): none,东盟(ASEAN): none。
- Q3. 棕榈酸异丙酯 (ISOPROPYL PALMITATE) 的常规配方添加量 (Layer 3) 与最佳稳定 pH 窗口是多少?
- 在代表性剂型 (anhydrous_balm) 中常规添加量为 2%–30%(中位数 5%),最佳稳定 pH 范围为 4–8。
- Q4. 棕榈酸异丙酯 (ISOPROPYL PALMITATE) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
- 推荐协同组合包括 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL;配伍禁忌注意:Verify phase compatibility under extreme pH or high electrolyte loads。