🇲🇾 NPRA — PKKK/200/UP/002 & PKKK/300/UP/031
◈ Seksyen Pengujian Produk & Kosmetik · Unit Penyaringan
Lovastatin HPLC Assay & Reporting
Interactive Calculation, System Suitability & Official Report Generator (Rekod Kualiti UP/008A–G)
Standardized analysis engine for the determination of Lovastatin in traditional health supplements. Includes automated System Suitability (SST) %RSD verification, 5-point calibration regression, %w/w assay, daily dose evaluation against NPRA limits (≤1.00% w/w, ≤10.00 mg/day), and printable test report drafting.
Column Thermo ODS Hypersil 200×4.6mm 5µm
Mobile Phase ACN : 0.05% H₃PO₄ (60:40 v/v)
Flow Rate 1.8 mL/min @ 45°C
Wavelength UV/PDA 238 nm
Run Time 6.0 min (Lovastatin ~4.0 min)
LOD 0.6 µg/mL (300 mg/kg)
Working Standard 20 µg/mL Peak Areas
Criteria: T < 2.0
Target: ~4.0 min
SST Evaluation Summary
Mean Peak Area:
1,247,567
Std Deviation (SD):
2,883.51
Peak Area %RSD:
0.23%
%RSD Acceptance (≤ 2.0%):
PASSED ✓
Tailing Factor (< 2.0):
PASSED ✓
| Standard Level | Conc (µg/mL) | Peak Area |
|---|---|---|
| Std 1 | ||
| Std 2 | ||
| Std 3 | ||
| Std 4 | ||
| Std 5 | ||
| LOD Check |
Regression & Linearity Results
Regression Equation:
y = 62410x + 1200
Slope (m):
62,410.00
Intercept (c):
1,200.00
Correlation Coeff (r²):
0.9999
Linearity Acceptance (r² ≥ 0.999):
PASSED ✓
LOD Area Threshold:
37,500 Area Counts
Sample Information & Test Parameters
Gravimetric & Chromatographic Inputs
Dissolved in 100 mL flask
From Borang UP/008B (Berat Purata)
e.g., 2 capsules taken per day
Quantitation & Compliance Evaluation
Mean Sample Peak Area:
1,382,000
Lovastatin Concentration in Flask:
22.12 µg/mL
Identification Status:
DIKESAN (DETECTED)
Lovastatin Content (% w/w):
0.438 % w/w
NPRA % w/w Limit (≤ 1.00% w/w):
LULUS (PASS)
Lovastatin per Capsule (mg/capsule):
1.97 mg / cap
Total Daily Dose (mg/day):
3.94 mg / day
NPRA Dose Limit (≤ 10.00 mg/day):
LULUS (PASS)
KERAJAAN MALAYSIA · KEMENTERIAN KESIHATAN MALAYSIA
PUSAT KOMPLIANS DAN KAWALAN KUALITI (PKKK)
SEKSYEN PENGUJIAN PRODUK & KOSMETIK — UNIT PENYARINGAN
LAPORAN UJIAN IDENTIFIKASI & PENENTUAN KANDUNGAN LOVASTATIN
No. Dokumen: PKKK/UP/008A (PKKK/200/UP/002)
1. MAKLUMAT SAMPEL
| No. Pendaftaran Sampel: | 26/UAT/0145 | Tarikh Ujian: | 22 Ogos 2026 |
| Nama Produk: | Red Yeast Rice Complex Capsule | Bentuk Dosej: | Kapsul |
| Kaedah / SOP Rujukan: | PKKK/200/UP/002 & PKKK/300/UP/031 (HPLC Technique) | ||
2. KEPUTUSAN KESESUAIAN SISTEM (SYSTEM SUITABILITY TEST)
| Parameter | Kriteria Had | Keputusan Diperolehi | Status |
|---|---|---|---|
| %RSD Puncak Piawai (n=6, 20 µg/mL) | ≤ 2.0% | 0.23% | LULUS |
| Tailing Factor (T) | < 2.0 | 1.15 | LULUS |
| Kelinearan Graf Kalibrasi (r²) | ≥ 0.999 | 0.9999 | LULUS |
3. PENGIRAAN & KEPUTUSAN UJIAN SAMPEL
| Berat Sampel Ditimbang (g): | 0.5024 g | Berat Purata Kandungan (g): | 0.4500 g |
| Purata Keluasan Puncak Sampel: | 1,382,000 | Kepekatan Larutan Sampel: | 22.12 µg/mL |
| Ujian Identifikasi Lovastatin: | DIKESAN (Spektrum UV & Waktu Penahanan sepadan dengan Piawai Rujukan Lovastatin) | ||
| Kandungan Lovastatin (% w/w): | 0.438 % w/w | Had Spesifikasi NPRA: | ≤ 1.00 % w/w |
| Kandungan Lovastatin per Kapsul: | 1.97 mg / kapsul | Dos Pengambilan Harian: | 2 kapsul / hari |
| Jumlah Dos Harian Lovastatin: | 3.94 mg / hari | Had Spesifikasi NPRA: | ≤ 10.00 mg / hari |
4. KESIMPULAN / PERAKUAN UJIAN
Sampel ini MEMATUHI SPESIFIKASI had kandungan Lovastatin yang ditetapkan oleh NPRA (Kandungan ≤ 1.00% w/w dan Dos Harian ≤ 10.00 mg/hari). Keputusan: LULUS (PASS).
(Nama Penganalisis)
Penolong Pegawai Farmasi (Penganalisis)
Tarikh: ___/___/2026
(Nama Pegawai Pemeriksa)
Pegawai Farmasi Pemeriksa Silang / Ketua Unit
Tarikh: ___/___/2026