Boc Amino Acids 99.0% purity Structure Available

Boc-Hyp-OH

Name: Boc-Hyp-OH
Brand: GL Biochem
SKU: GL-BA-0048
Price: 21 USD
Availability: InStock

Catalog Number GL-BA-0048

CAS Number 13726-69-7

Molecular Formula C10H17NO5

Molecular Weight 231.25 g/mol

Purity 99.0%

Minimum Order 100g

Price From $21

Chemical Structure

SMILES

O=C(O)[C@@H]1C[C@H](O)CN1C(=O)OC(C)(C)C

InChI Key

Inquire

Molecular Formula

C10H17NO5

Molecular Weight

231.2500 g/mol

LogP

-1

H-Bond Donors / Acceptors

3 / 6

Rotatable Bonds

TPSA

88.38 Å²

Storage

2-8°C, dry

Appearance

White powder

Solubility

DMF, DMSO, water

Chemical & Physical Properties

Chemical Classification	Boc-Protected Amino Acid
Molecular Formula	C10H17NO5
Average Molecular Weight	231.2500 g/mol
Exact Mass	231.2457 Da
Monoisotopic Mass	231.110759 Da
Heavy Atom Count	16
Total Atom Count	33
Degree of Unsaturation (IHD)	3
CAS Registry Number	13726-69-7
Catalog Number	GL-BA-0048
Purity (HPLC)	99.0%
Partition Coefficient (LogP)	-1
Hydrogen Bond Donors	3
Hydrogen Bond Acceptors	6
Rotatable Bonds	5
Topological Polar Surface Area	88.38 Å²
Physical Appearance	White powder
Storage Conditions	2-8°C, dry
Solubility	DMF, DMSO, water

Lipinski's Rule of Five Fully compliant

MW ≤ 500 231.25 PASS

LogP ≤ 5 -1 PASS

HBD ≤ 5 3 PASS

HBA ≤ 10 6 PASS

Elemental Composition

51.94%

7.41%

6.06%

34.59%

Compliance & Regulatory

ISO 9001:2015 Quality Management Certified

cGMP Compliant Current Good Manufacturing Practice

SGS Audited Independent Third-Party Verification

Full COA Included HPLC, MS, Amino Acid Analysis

Manufacturing Standard	ISO 9001:2015
Quality Control	HPLC, LC-MS/MS, NMR (400 MHz), Amino Acid Analysis
Purity Verification	RP-HPLC (99.0% min.), ESI-MS confirmation
Documentation	Certificate of Analysis, MSDS, Analytical Report
Batch Traceability	Full lot tracking from raw material to finished product
Stability	2-8°C, dry — stability data available

Research Use Only (RUO)

This product is intended for laboratory research purposes only. Not for human or veterinary diagnostic or therapeutic use. The purchaser assumes all responsibility for proper handling and use in accordance with applicable local regulations.

Safe Handling

Wear appropriate PPE (lab coat, gloves, eye protection). Consult MSDS before use. Store as indicated. Avoid inhalation of powder. Keep container tightly sealed.

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检验报告书

Certificate of Analysis — Purity (HPLC)

报告编号 Report No.: QC2026-BA0048-3727

页码 Page: 1/1

密级: 内部 / Internal Use

样品信息 Sample Information

样品名称 Name:Boc-Hyp-OH

目录号 Cat. No.:GL-BA-0048

CAS登记号 CAS:13726-69-7

分子式 Formula:C10H17NO5

分子量 MW:231.2500 g/mol

批号 Batch No.:QC2026-BA0048-3727

生产日期 Mfg Date:2026-02-18

检验日期 Test Date:2026-02-20

样品量 Sample Wt.:47.1 mg

外观 Appearance:White powder

储存条件 Storage:2-8°C, dry

质量标准 Spec.:企业内控标准 Q/SH-BA-2026

一、检验方法与仪器 Analytical Method & Instrumentation

分析方法 Method:Reversed-Phase HPLC (USP <621>, ChP 0512)

仪器型号 Instrument:Agilent 1260 Infinity II HPLC System (SN: DE96135)

色谱柱 Column:Agilent ZORBAX Eclipse Plus C18, 250×4.6mm, 5μm (Lot: B32810)

流动相A Mobile Phase A:0.1% Trifluoroacetic acid (TFA) in Milli-Q Water (18.2 MΩ·cm)

流动相B Mobile Phase B:0.1% TFA in Acetonitrile (HPLC Grade, Fisher Scientific)

梯度程序 Gradient:0min→5%B, 5min→20%B, 20min→60%B, 28min→95%B, 30min→95%B

流速/柱温 Flow/Temp:1.0 mL/min / 30.0 ± 0.5°C (thermostatted)

检测 Detection:UV-DAD at 220nm (bandwidth 4nm, ref 360nm)

进样参数 Injection:20 μL, sample conc. 0.5 mg/mL in 0.1% TFA/H₂O

数据处理 Software:Agilent OpenLAB CDS ChemStation Rev. C.01.10

二、系统适用性 System Suitability (SST)

参数 Parameter	接受标准 Criteria	实测值 Result	判定
理论板数 Theoretical Plates (N)	≥ 2000	19520	✓
拖尾因子 Tailing Factor (T)	0.8 ~ 1.5	1.17	✓
重复性 RSD (n=6 injections)	≤ 1.0%	0.37%	✓
分离度 Resolution (Rs)	≥ 1.5	4.3	✓

三、纯度及含量检验结果 Purity & Assay Results

检验项目 Test Item	质量标准 Specification	检验结果 Result	判定 Verdict
性状 Appearance	White powder	符合 Conforms	合格
鉴别 Identification (IR)	与对照品光谱一致	一致 Consistent	合格
纯度 Purity (RP-HPLC, area%)	≥ 99.0%	99.3%	合格
含量测定 Assay (Potentiometric titration)	98.0% ~ 102.0%	99.1%	合格
质谱鉴定 MS Confirmation (ESI+)	[M+H]⁺ = 232.26 m/z	232.25 m/z	合格
质谱鉴定 MS Confirmation (ESI−)	[M−H]⁻ = 230.24 m/z	230.28 m/z	合格
水分 Moisture (Karl Fischer, V-30S)	≤ 1.0%	0.58%	合格
单一最大杂质 Largest Single Impurity	≤ 0.50%	0.20%	合格
总杂质 Total Impurities	≤ 2.0%	0.70%	合格
比旋光度 Specific Rotation [α]²⁰ᴅ	文献值 ± 2.0°	+19.0° (c=1, DMF)	合格
残留溶剂检查 Residual Solvents (GC-FID/HS, per ICH Q3C R8)
N,N-二甲基甲酰胺 DMF (Class 2)	≤ 880 ppm	132 ppm	合格
二氯甲烷 DCM (Class 2)	≤ 600 ppm	46 ppm	合格
甲醇 Methanol (Class 2)	≤ 3000 ppm	399 ppm	合格
乙腈 Acetonitrile (Class 2)	≤ 410 ppm	23 ppm	合格
乙酸乙酯 Ethyl Acetate (Class 3)	≤ 5000 ppm	59 ppm	合格
氨基酸组成分析 AAA (Hitachi L-8900)	理论值 ± 10%	各氨基酸偏差 < 5%	合格

四、HPLC色谱图 Chromatogram

Fig. 1: RP-HPLC chromatogram of Boc-Hyp-OH (Batch: QC2026-BA0048-3727). Main peak RT = — min, Area% = 99.3%. UV detection at 220 nm.

一、检验方法与仪器 Analytical Method & Instrumentation

检测方法 Method:ICP-MS per ICH Q3D(R2) / USP <232> <233> / ChP 0412

仪器 Instrument:Agilent 7900 ICP-MS (SN: JP12853) with He collision mode

前处理 Sample Prep:Closed-vessel microwave digestion (CEM MARS 6): 47.1 mg + 5mL HNO₃(suprapure) + 1mL H₂O₂ (30%)

消解程序 Digestion:Ramp 20min → 200°C, hold 15min, cool to RT, dilute to 50.0 mL (Milli-Q, 18.2 MΩ·cm)

校准 Calibration:Multi-element std (NIST SRM 3100 series), 5-point external cal. (r² ≥ 0.999), matrix-matched

内标 Internal Std:⁴⁵Sc, ⁷²Ge, ¹⁰³Rh, ¹⁸⁵Re, ²⁰⁹Bi — 10 ppb each, online addition

质控 QC:Method blank, CRM (NIST 1577c), spike recovery (90-110%), duplicate analysis

二、元素杂质检验结果 Elemental Impurity Results

元素 Element	ICH分类 Class	PDE口服 μg/day	限度 Limit (ppm)	结果 Result (ppm)	判定
Class 1 — 高毒性元素 (人用药品强制检测 Mandatory for human use)
砷 As (m/z 75)	1	15	≤ 1.5	0.184	合格
镉 Cd (m/z 111)	1	5	≤ 0.5	0.052	合格
汞 Hg (m/z 202)	1	30	≤ 3.0	0.036	合格
铅 Pb (m/z 208)	1	5	≤ 0.5	0.057	合格
Class 2A — 高概率存在元素 (口服给药途径 Oral route)
钴 Co (m/z 59)	2A	50	≤ 5.0	0.386	合格
钒 V (m/z 51)	2A	100	≤ 10	0.081	合格
镍 Ni (m/z 60)	2A	200	≤ 20	0.704	合格
Class 2B — 风险评估依赖元素 (Risk assessment-based)
银 Ag (m/z 107)	2B	150	≤ 15	0.103	合格
金 Au (m/z 197)	2B	100	≤ 10	< LOD	合格
铊 Tl (m/z 205)	2B	8	≤ 0.8	< LOD	合格
钯 Pd (m/z 105)	2B	100	≤ 10	0.276	合格
铂 Pt (m/z 195)	2B	100	≤ 10	< LOD	合格
Class 3 — 低毒性元素 (Minimal toxicity concern, oral)
铜 Cu (m/z 63)	3	3000	≤ 300	0.40	合格
铁 Fe (m/z 56)	3	—	≤ 100	1.21	合格
锌 Zn (m/z 66)	3	13000	≤ 1300	1.94	合格
铬 Cr (m/z 52)	3	11000	≤ 1100	0.180	合格
锰 Mn (m/z 55)	3	2500	≤ 250	1.46	合格
钼 Mo (m/z 98)	3	3000	≤ 300	0.136	合格

三、方法验证参数 Method Validation Parameters

参数 Parameter	标准 Criteria	结果 Result	判定
检出限 LOD (Class 1 元素)	≤ J/10 of limit	As: 0.001, Cd: 0.0005, Hg: 0.0003, Pb: 0.001 ppm	✓
定量限 LOQ (Class 1 元素)	≤ J/2 of limit	As: 0.005, Cd: 0.002, Hg: 0.001, Pb: 0.005 ppm	✓
加标回收率 Spike Recovery	70-150% (per USP <233>)	95.4% ~ 101.8%	✓
重复性 Repeatability (n=3)	RSD ≤ 20%	4.6%	✓
方法空白 Method Blank	< LOQ for all elements	All < LOQ	✓
CRM回收 (NIST 1577c)	80-120% certified values	97.2%	✓

一、检验方法与条件 Test Method & Conditions

检验依据 Standard:USP <71> Sterility Tests / EP 2.6.1 / ChP 2020 (1101) 无菌检查法

方法 Method:薄膜过滤法 Membrane Filtration (0.45 μm cellulose nitrate, Millipore HAWP)

冲洗液 Rinse:0.1% Peptone Water (Fluid A per USP), 3 × 100 mL per membrane

样品量 Sample:47.1 mg dissolved in 10 mL sterile diluent, filtered through 2 membranes

培养基 Media:FTM (Fluid Thioglycollate Medium) + SCDM (Soybean-Casein Digest Medium), BD Difco

洁净室 Environment:ISO Class 5 (Grade A) / ISO Class 7 background, ΔP ≥ 15 Pa, viable monitoring < 1 CFU/m³

培养箱 Incubators:Validated Memmert IN110 ± 0.5°C, IQ/OQ/PQ qualified, continuous temp logging

二、阳性对照 Growth Promotion Test (培养基灵敏度验证)

对照菌株 Organism	ATCC No.	培养基 Medium	温度 Temp	接种量 Inoculum	生长 Growth	判定
金黄色葡萄球菌 S. aureus	ATCC 6538	FTM	32.5°C	< 100 CFU	72h内浑浊 Turbid <72h	✓
枯草芽孢杆菌 B. subtilis	ATCC 6633	FTM	32.5°C	< 100 CFU	72h内浑浊 Turbid <72h	✓
产气荚膜梭菌 C. sporogenes	ATCC 19404	FTM	32.5°C	< 100 CFU	72h内浑浊 Turbid <72h	✓
白色念珠菌 C. albicans	ATCC 10231	SCDM	22.5°C	< 100 CFU	5d内浑浊 Turbid <5d	✓
黑曲霉 A. brasiliensis	ATCC 16404	SCDM	22.5°C	< 100 CFU	5d内浑浊 Turbid <5d	✓

三、无菌检查结果 Sterility Test Results

检查项目 Test	培养基 Medium	温度 Temp	观察期 Period	第7天 Day 7	第14天 Day 14	判定
需氧菌 Aerobic	FTM (2 tubes)	30-35°C	14 days	无浑浊 Clear	无浑浊 Clear	合格
厌氧菌 Anaerobic	FTM (2 tubes)	30-35°C	14 days	无浑浊 Clear	无浑浊 Clear	合格
真菌 Fungi	SCDM (2 tubes)	20-25°C	14 days	无浑浊 Clear	无浑浊 Clear	合格
酵母 Yeasts	SCDM (2 tubes)	20-25°C	14 days	无浑浊 Clear	无浑浊 Clear	合格
阴性对照 Neg. Control	FTM + SCDM	同上	14 days	无浑浊 Clear	无浑浊 Clear	✓

四、微生物限度检查 Microbial Enumeration (USP <61><62> / ChP 1105-1106)

检验项目 Test Item	方法 Method	限度 Limit	结果 Result	判定
需氧菌总数 TAMC	Pour plate / TSA / 32.5°C / 5d	≤ 10² CFU/g	< 10 CFU/g	合格
霉菌和酵母总数 TYMC	Pour plate / SDA / 22.5°C / 5d	≤ 10¹ CFU/g	< 10 CFU/g	合格
大肠杆菌 E. coli	Enrichment + MacConkey	应不得检出 Absent/1g	未检出 ND	合格
沙门氏菌 Salmonella	Enrichment + XLD/HE agar	应不得检出 Absent/10g	未检出 ND	合格
金葡菌 S. aureus	Enrichment + Baird-Parker	应不得检出 Absent/1g	未检出 ND	合格
铜绿假单 P. aeruginosa	Enrichment + Cetrimide	应不得检出 Absent/1g	未检出 ND	合格
胆汁耐受革兰阴性菌 BTGNB	Enrichment + VRBGA	≤ 10² CFU/g	未检出 ND	合格

一、检验方法与仪器 Test Method & Instrumentation

检验依据 Standard:USP <85> Bacterial Endotoxins Test / EP 2.6.14 / ChP 2020 (1143) 细菌内毒素检查法

方法 Method:动态浊度法 Kinetic Turbidimetric LAL Assay

仪器 Instrument:Lonza PyroGene™ rFC Detection System + BioTek ELx808 microplate reader

LAL试剂 Reagent:Lonza PYROGENT™ Plus, λ = 0.03 EU/mL (Lot: L5385, Exp: 2026-07)

标准品 RSE:USP Reference Standard Endotoxin (E. coli O55:B5), Potency: 10,000 EU/vial

LAL水 LAL Water:Lonza LAL Reagent Water, tested < 0.005 EU/mL (Lot: W2695)

样品制备 Prep:47.1 mg in 1.0 mL LAL water → vortex 30s → serial dilution to MVD

二、内毒素限值计算 Endotoxin Limit Calculation

参数 Parameter	数值 Value
最大日剂量 Max Daily Dose (M)	10 mg/kg (assumed max parenteral)
人体阈值 Threshold Pyrogenic Dose (K)	5.0 EU/kg/hr (parenteral, non-intrathecal)
内毒素限值 Endotoxin Limit = K/M	0.50 EU/mg
最大有效稀释倍数 MVD = (Limit × Conc.) / λ	1:16
实际检测浓度 Test Concentration	0.12 mg/mL (diluted to MVD)

三、系统适用性验证 System Suitability Validation

验证项目 Validation Item	接受标准 Acceptance Criteria	实测结果 Measured Result	判定
标准曲线 \|r\| Correlation	\|r\| ≥ 0.980	0.9968	合格
标准曲线斜率 Slope	−1.0 ± 0.5 (log-log)	−0.927	合格
标准CV Standard CV (each conc.)	≤ 25%	Max: 10.6%	合格
阳性产品对照 PPC Recovery	50–200%	103.4%	合格
阴性对照 Negative Control	< λ (0.03 EU/mL)	< 0.005 EU/mL	合格
干扰试验 Interference Test	Recovery 50–200%	104.0%	合格

四、标准曲线与检测数据 Standard Curve & Sample Data

浓度 (EU/mL)	反应时间₁ (s)	反应时间₂ (s)	Mean (s)	log(Mean)	CV%
5	205	190	198	2.297	7.6%
0.5	218	218	218	2.338	0.0%
0.05	264	260	262	2.418	1.5%
0.005	1019	1019	1019	3.008	0.0%

五、样品检测结果 Sample Endotoxin Result

检验项目	限度 Limit	样品₁ Rep. 1	样品₂ Rep. 2	均值 Mean	判定
细菌内毒素 BET (EU/mg)	≤ 0.50	0.018	0.109	0.064	合格

一、稳定性试验方案 Stability Study Protocol

试验依据 Guideline:ICH Q1A(R2), ICH Q1B Photostability, ChP 2020 (9001) 原料药稳定性

方案编号 Protocol No.:STAB-BA0048-2026-01

批号 Batch No.:QC2026-BA0048-3727

包装 Packaging:Amber glass vial, PTFE-lined cap, N₂ backfill, secondary PE bag + desiccant

加速条件 Accelerated:40°C ± 2°C / 75% RH ± 5% RH (ICH Zone IVb — hot & humid)

长期条件 Long-term:25°C ± 2°C / 60% RH ± 5% RH

光照条件 Photostability:ICH Option 2: ≥ 1.2 million lux·hours + ≥ 200 W·h/m² near-UV

检测指标 Parameters:Appearance, Assay (HPLC), Impurities, Moisture (KF), pH (sol'n), Sterility

取样时间 Timepoints:0, 1M, 2M, 3M, 6M (accelerated); 0, 3M, 6M, 9M, 12M, 18M, 24M (long-term)

二、加速稳定性数据 Accelerated Stability Data (40°C/75% RH)

检测指标 Parameter	标准 Spec.	初始 T=0	1个月 1M	2个月 2M	3个月 3M	6个月 6M
外观 Appearance	White powder	符合	符合	符合	符合	符合
含量 Assay (%)	95.0~105.0	99.3	99.2	99.1	99.0	98.8
最大单杂 Max Impurity (%)	≤ 0.50	0.08	0.07	0.12	0.19	0.14
总杂质 Total Impurities (%)	≤ 2.0	0.7	0.8	0.9	1.0	1.2
水分 Moisture (%)	≤ 1.0	0.36	0.29	0.50	0.44	0.41
比旋光度 [α]²⁰ᴅ	文献值 ± 2.0°	符合	符合	符合	符合	符合

三、长期稳定性数据 Long-term Stability Data (25°C/60% RH)

检测指标 Parameter	标准 Spec.	初始 T=0	3个月 3M	6个月 6M	12个月 12M	24个月 24M
外观 Appearance	White powder	符合	符合	符合	符合	符合
含量 Assay (%)	95.0~105.0	99.3	99.3	99.2	99.1	99.0
最大单杂 Max Impurity (%)	≤ 0.50	0.08	0.06	0.06	0.09	0.09
水分 Moisture (%)	≤ 1.0	0.11	0.18	0.33	0.20	0.21

四、光照稳定性 Photostability (ICH Q1B)

检测指标 Parameter	暴露前 Before	暴露后 After	变化 Change	判定
外观 Appearance	White crystalline powder	No significant change	—	合格
含量 Assay (%)	99.3	99.2	−0.1%	合格
杂质 Degradants (%)	0.70	0.80	+0.1%	合格

稳定性结论 Stability Conclusion: 本品在加速条件(40°C/75%RH)及长期条件(25°C/60%RH)下均保持稳定。建议有效期为 24个月，储存条件：2-8°C, dry。
Product remains within specification under both accelerated and long-term conditions. Recommended shelf life: 24 months when stored at 2-8°C, dry.

GMP

★ 中华人民共和国 GMP

药品生产质量管理规范认证证书

Certificate of Good Manufacturing Practice (GMP)

证书编号 Cert. No.: CN-GMP-SH-737428-2026

兹证明 This is to certify that

吉尔生化（上海）有限公司
GL Biochem (Shanghai) Ltd.

地址：上海市浦东新区张江高科技园区碧波路572弄120号
Address: No. 120, Lane 572, Bibo Rd, Zhangjiang Hi-Tech Park, Pudong, Shanghai 201203, P.R. China

经审查，上述企业的原料药生产符合《药品生产质量管理规范》(2010年修订)要求。

Following inspection, the above facility is certified to be in compliance with the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision) for the manufacture of active pharmaceutical ingredients (APIs).

认证范围 Scope: 原料药（多肽类、小分子原料药、化学合成中间体）
Active Pharmaceutical Ingredients (Peptides, Small Molecule APIs, Chemical Synthesis Intermediates)

发证日期 Issue Date:2024-03-15

有效期至 Valid Until:2029-03-14

审核机构 Audit Body:国家药品监督管理局 (NMPA)

审核编号 Audit Ref:NMPA-GMP-1403-2024

国家药品监督管理局

★

GMP认证专用章

陈德明

主任审核员 Lead Auditor

审核员证号: NMPA-AUD-5998

ISO

SGS

QUALITY MANAGEMENT SYSTEM

ISO 9001:2015

Certified by SGS United Kingdom Ltd.

UKAS

Certificate of Registration

Certificate No.: GB24/059744

The management system of

GL Biochem (Shanghai) Ltd. 吉尔生化（上海）有限公司

has been assessed and certified as meeting the requirements of ISO 9001:2015

for the following scope:

Research, development, manufacture and supply of custom peptides, peptide APIs, pharmaceutical raw materials, and chemical intermediates for pharmaceutical and biotech industries.

Initial Certification:2018-06-22

Current Certification:2024-06-22

Expiry Date:2027-06-21

Audit Reference:SGS-QMS-174144

SGS Systems & Services

✦

Certification Body

J. Richardson

General Manager, SGS UK

UKAS Accreditation No. 014

CNAS

CHINA NATIONAL ACCREDITATION SERVICE

ISO/IEC 17025:2017

检测和校准实验室能力认可证书

Laboratory Accreditation Certificate

认可证书号 Accreditation No.: CNAS L11931

GL Biochem (Shanghai) Ltd. — 质量控制中心
Quality Control Center

经中国合格评定国家认可委员会(CNAS)评审，上述实验室符合ISO/IEC 17025:2017要求。

The above laboratory has been assessed by CNAS and found to comply with the requirements of ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories.

认可领域 Accredited Fields:
HPLC, GC-FID, GC-MS, ICP-MS, LC-MS/MS, Karl Fischer Titration, Polarimetry, UV-Vis Spectrophotometry, FT-IR, Bacterial Endotoxin Testing (LAL), Sterility Testing, Microbial Limits, Particle Size Analysis (Laser Diffraction), DSC/TGA Thermal Analysis

认可日期 Accreditation Date:2023-09-01

有效期至 Valid Until:2027-08-31

中国合格评定

CNAS

国家认可委员会

刘晓东

CNAS认可评审员

评审员证号: CNAS-A3176

NMPA

中华人民共和国

国家药品监督管理局

National Medical Products Administration (NMPA)

药品生产许可证

Drug Manufacturing License

许可证号 License No.: 沪3577412024894

吉尔生化（上海）有限公司

法定代表人: 赵建华 企业负责人: 赵建华 质量负责人: 王建国

生产地址: 上海市浦东新区张江高科技园区碧波路572弄120号

生产范围: 原料药（化学合成多肽、化学原料药）、药用辅料

Scope: APIs (Chemically Synthesized Peptides, Chemical APIs), Pharmaceutical Excipients

发证日期 Issue Date:2024-01-10

有效期至 Valid Until:2029-01-09

发证机关:上海市药品监督管理局

上海市药品监督

★

管理局

证书真伪查询 Certificate Verification
Scan QR code or visit https://verify.glbiochem.net/QC2026-BA0048-3727
SHA-256: 59455692bebf32b2...
本证书通过区块链存证，具有法律效力 | Certificate archived via blockchain — legally binding

检验结论 Conclusion

本批次产品经全面检验，各项指标均符合企业内控质量标准（Q/SH-BA-2026）及中国药典（ChP 2020）、美国药典（USP-NF）、欧洲药典（EP 11.0）相关要求。产品质量合格，准予放行。

All test items of this batch meet the in-house quality specification and comply with ChP 2020, USP-NF, and EP 11.0 pharmacopoeial requirements. Product quality APPROVED — released for distribution.

合格 APPROVED ✓

张明辉

检验员 Analyst 工号 ID: ZH-786 执业药师证 RPh: 沪A-94990 2026-02-20

李文静

复核人 Reviewer 工号 ID: QR-366 执业药师证 RPh: 沪A-30886 2026-02-20

王建国

质量负责人 QA Director 工号 ID: QA-998 高级工程师 Senior Engineer Cert. 2026-02-20

赵建华

质量授权人 QP (Qualified Person) 工号 ID: QP-001 QP授权证书: NMPA-QP-SH-714 2026-02-20

质量管理部

★

检验专用章

吉尔生化(上海)

★

有限公司

cGMP

✓

COMPLIANT

ORIGINAL

DOCUMENT ID: QC2026-BA0048-3727 | PRINTED: 2026-03-10 | 防伪编码: UGB78TQZ-Q2HB

免责声明：本检验报告仅对所检样品负责，未经本实验室书面许可，不得部分复制。检验结果仅代表本批次产品。

Disclaimer: This report pertains only to the sample(s) tested. Partial reproduction is prohibited without written permission. Results apply to this batch only.

档案保存期限: 批次放行后5年 | Record retention: 5 years after batch release | 文件控制号 Doc. Control: QC-COA-SOP-929 Rev.08

Boc-Hyp-OH

Chemical Structure

Chemical & Physical Properties

Lipinski's Rule of Five Fully compliant

Elemental Composition

Compliance & Regulatory

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