Azelaic acid 98%by HPLC | Farmashiiyaha & Darajada Isqurxinta
1. Dulmarka alaabta
Azelaic acid(CAS123-99-9) waa dicarboxylic acid si dabiici ah u dhacda oo leh qaacido molecular C₉H₁₆O₄ iyo miisaanka kelli 188.22 g/mol. Darajadayada nadiifinta ee HPLC ee la xaqiijiyay 98% waxay la kulmeysaa heerarka USP/EP, oo loo habeeyay hababka maqaarka iyo codsiyada warshadaha.
Tilmaamaha Muhiimka ah
- Daahirsanaanta: ≥98% (HPLC-ELSD waa la ansaxiyay, wadarta wasakhda <0.2%)
- Muuqaalka: Budada crystalline cad
- Meesha dhalaalaysa: 109-111°C
- Barta karkarinta: 286°C at 100 mmHg
- Solubility: 2.14 g/L biyaha (25°C), ku milmay xalalka ethanol/alkaline
2. Tilmaamaha Kiimikada
2.1 Xaqiijinta Qaabdhismeedka
- Profile 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 (t, 2H), 1.2H kasta, 1.2H COOH) - HPLC Chromatogram:
Waqtiga Haynta: 20.5 min (ugu sarreysa), wasakhda ugu sarreysa <0.1% at 31.5/41.5 min
2.2 Nidaamka Xakamaynta Tayada
| Halbeegga | Habka | Shuruudaha Ogolaanshaha |
|---|---|---|
| Qiimayn | HPLC-ELSD (Agilent 1200) Tiirka: Purospher Star RP-C18 Wajiga wareega: Methanol/Biyaha/Acetic acid gradient | 98.0-102.0% |
| Biraha culus | ICP-MS | ≤10 ppm |
| Xalalka Haraaga ah | GC-FID (HP-5MS tiirka) Kala soocida HMDS | Ethanol <0.5% |
3. Codsiyada dawooyinka
3.1 Waxtarka Maqaarka
- Acne Vulgaris:
Waxay ku yaraynaysaa majaajilada 65% 12-usbuuc ee tijaabada ah (20% kareem) iyada oo loo marayo:- Tallaabo lid ku ah jeermiskaC. finanka(MIC₅₀ 256 μg/ml)
- Joojinta Tyrosinase (IC₅₀ 3.8 mM) ee hyperpigmentation post-bararka
- Rosacea:
15% jel waxay muujinaysaa 72% hoos u dhaca erythema (Vs 43% placebo) iyada oo loo marayo:- Antioxidant ROS xoqida (EC₅₀ 8.3 μM)
- Cadaadiska MMP-9 ee keratinocytes
3.2 Tilmaamaha qaabeynta
| Foomka qiyaasta | lagu taliyay % | Qoraalada Waafaqid |
|---|---|---|
| Kareem/Jeel | 15-20% | Iska ilaali methylparaben (waxay sababtaa 42% hoos u dhaca) |
| Liposomal | 5-10% | Isticmaal fosfooraska kaydka pH7.4 + lecithin soybean |
4. Codsiyada qurxinta
4.1 Isku-dhafka Cadaadiska
- Isku darka ugu Fiican:
- 2% AzA + 5% Vitamin C: 31% dhimista melanin vs monotherapy
- 1% AzA + 0.01% retinol: 2x kolajka synthesis kor u kaca
4.2 Xogta Xasiloonida
| Xaalad | Heerka hoos u dhaca |
|---|---|
| 40°C/75% RH (3M) | <0.5% |
| Soo-gaadhista UV | 1.2% (oo leh ilaalinta TiO₂) |
5. Isticmaalka Warshadaha
- Polymer Precursor:
- Nylon-6,9 synthesis (wax soo saarka falcelinta>85% at 220°C)
- Xakamaynta daxalka ee alwaaxyada birta (xalka 0.1M wuxuu yareeyaa daxalka 92%)
6. Badbaadada & Nidaaminta
6.1 Profile Sun
| Halbeegga | Natiijada |
|---|---|
| LD₅₀ Afka Ba'an (Jiir) | >5000 mg/kg |
| Xanaaq maqaarka | Fudud (OECD 404) |
| Khatarta indhaha | Qaybta 2B |
6.2 U Hogaansanaanta Caalamiga ah
- Shahaadooyinka:
- US FDA Drug Master File
- EU REACH waa diiwaan gashan tahay
- ISO 9001: 2015 Nidaamka Tayada
7. Baakadaha & Kaydinta
| Tirada | Konteenar | Qiimaha (EXW) |
|---|---|---|
| 25 kg | durbaan HDPE + Alu bac | $4,800 |
| 1 kg | Dhalada dhalada Amber | $220 |
| 100 g | Kiishka laba-laaban leh | $65 |
Kaydinta: 2-8°C deegaanka qallalan (kulka qolka waa la aqbali karaa haddii <25°C/60% RH)
8. FAQs
S: Ma ku isticmaali karaa azelaic acid niacinamide?
J: Haa, xogta caafimaadku waxay muujinaysaa 10% AzA + 4% niacinamide waxay hagaajinaysaa dulqaadka 37% vs AzA
S: Waa maxay nolosha shelfiska?
J: 36 bilood marka si fiican loo kaydiyo. Dufcad-gaar ah COA ayaa bixisay
9. Tixraacyo
- Xogta sifaha NMR
- Habka HPLC-ELSD
- Daraasadaha xasilloonida
- Waxtarka bukaan-socodka
