Azelaic Acid 98%ndi HPLC | Pharmaceutical & Cosmetic Grade
1. Mwachidule cha mankhwala
Azelaic Acid(CAS123-99-9) ndi dicarboxylic acid yomwe imachitika mwachilengedwe yokhala ndi formula ya mamolekyulu C₉H₁₆O₄ ndi kulemera kwa molekyulu 188.22 g/mol. Gulu lathu lotsimikiziridwa ndi 98% la chiyero cha HPLC limakwaniritsa miyezo ya USP/EP, yokongoletsedwa ndi dermatological formulations ndi mafakitale.
Zofunika Kwambiri
- Chiyero: ≥98% (HPLC-ELSD yovomerezeka, zonyansa zonse <0.2%)
- Maonekedwe: ufa woyera wa crystalline
- Malo osungunuka: 109-111 ° C
- Malo Owira: 286 ° C pa 100 mmHg
- Kusungunuka: 2.14 g/L m'madzi (25°C), kusungunuka muzitsulo za ethanol/zamchere
2. Chemical Characterization
2.1 Kutsimikizira Kwamapangidwe
- Mbiri ya NMR:
¹H NMR (300 MHz, CDCl₃): δ 1.23 (t, J=7.1Hz, 3H), 1.26-1.39 (m, 6H), 1.51-1.69 (m, 4H), 2.26/2.32 (q, 4.10 H iliyonse), (q. s, COOH) - HPLC Chromatogram:
Nthawi Yosungira: 20.5 min (chinsonga chachikulu), nsonga zonyansa <0.1% pa 31.5 / 41.5 min
2.2 Quality Control Protocol
| Parameter | Njira | Zoyenera Kuvomereza |
|---|---|---|
| Kuyesa | HPLC-ELSD (Agilent 1200) Mzere: Purospher Star RP-C18 Mobile Phase: Methanol/Madzi/Acetic Acid gradient | 98.0-102.0% |
| Zitsulo Zolemera | ICP-MS | ≤10 ppm |
| Zosungunulira Zotsalira | GC-FID (gawo la HP-5MS) Kuchokera ku HMDS | Ethanol <0.5% |
3. Kugwiritsa Ntchito Mankhwala
3.1 Kuchita bwino kwa Dermatological
- Matenda a Vulgaris:
Amachepetsa ma comedones ndi 65% mu mayesero a masabata 12 (20% kirimu) kudzera:- Antimicrobial zochita motsutsanaC. ziphuphu(MIC₅₀ 256 μg/mL)
- Tyrosinase inhibition (IC₅₀ 3.8 mM) ya post-inflammatory hyperpigmentation
- Rosacea:
15% gel osakaniza akuwonetsa kuchepa kwa erythema ndi 72% (vs 43% placebo) kudzera:- Antioxidant ROS scavenging (EC₅₀ 8.3 μM)
- Kuponderezedwa kwa MMP-9 mu keratinocytes
3.2 Njira Zopangira
| Fomu ya Mlingo | Zovomerezeka % | Zolemba Zogwirizana |
|---|---|---|
| Kirimu / Gel | 15-20% | Pewani methylparaben (imayambitsa kuwonongeka kwa 42%) |
| Liposomal | 5-10% | Gwiritsani ntchito phosphate buffer pH7.4 + soya lecithin |
4. Zodzikongoletsera Mapulogalamu
4.1 Whitening Synergy
- Zosakaniza bwino:
- 2% AzA + 5% Vitamini C: 31% kuchepetsa melanin vs monotherapy
- 1% AzA + 0.01% Retinol: 2x collagen synthesis yowonjezera
4.2 Deta Yokhazikika
| Mkhalidwe | Degradation Rate |
|---|---|
| 40°C/75% RH (3M) | <0.5% |
| Kuwonekera kwa UV | 1.2% (ndi chitetezo cha TiO₂) |
5. Ntchito Zamakampani
- Polima Precursor:
- Nayiloni-6,9 kaphatikizidwe (zokolola zamachitidwe> 85% pa 220°C)
- Corrosion inhibitor yazitsulo zazitsulo (0.1M yankho limachepetsa dzimbiri ndi 92%)
6. Chitetezo & Kuwongolera
6.1 Mbiri ya Toxicological
| Parameter | Zotsatira |
|---|---|
| Acute Oral LD₅₀ (Khoswe) | > 5000 mg / kg |
| Khungu Kukwiya | Ochepa (OECD 404) |
| Chiwopsezo cha Ocular | Gulu 2B |
6.2 Global Compliance
- Zitsimikizo:
- US FDA Drug Master Fayilo
- EU REACH Adalembetsa
- ISO 9001:2015 Quality System
7. Kuyika & Kusungirako
| Kuchuluka | Chidebe | Mtengo (EXW) |
|---|---|---|
| 25kg pa | HDPE ng'oma + Chikwama cha Alu | $4,800 |
| 1 kg | Amber galasi botolo | $220 |
| 100 g pa | Thumba losindikizidwa kawiri | $65 |
Kusungirako: 2-8°C pamalo owuma (kutentha kovomerezeka ngati <25°C/60% RH)
8. Mafunso Ofunsidwa Kawirikawiri
Q: Kodi ndingagwiritse ntchito azelaic acid ndi niacinamide?
A: Inde, zidziwitso zachipatala zikuwonetsa 10% AzA + 4% niacinamide imathandizira kupirira 37% vs AzA yokha
Q: Kodi alumali moyo ndi chiyani?
A: Miyezi 36 ikasungidwa bwino. COA yeniyeni ya batch yaperekedwa
9. Maumboni
- Zithunzi za NMR
- Njira ya HPLC-ELSD
- Maphunziro okhazikika
- Kuchita bwino kwachipatala
