Clinical Trials

Coenzyme Q10 has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 to assess its therapeutic utility in cardiovascular dysfunction, non-alcoholic fatty liver disease, sarcopenia, progressive supranuclear palsy, and viral infections. Sponsored by various academic medical centers and research institutes, these protocols exhibit recruitment statuses ranging from completed and actively recruiting to withdrawn or not yet recruiting. Overall, these studies evaluate key endpoints including cardiac parameters, neurodegenerative outcomes, and metabolic dysfunction.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07234422 RECRUITING
Heart Failure
Netherlands Heart Institute
2026-05-04 PHASE3
NCT07668284 NOT_YET_RECRUITING
Prostate Cancer; Uterine Cancer; Cervical Cancer; Anal Cancer
University of Nebraska
2026-07-01 PHASE1; PHASE2
NCT06694727 RECRUITING
Heart Failure
Tor Biering-Sørensen
2025-09-30 PHASE3
NCT06962657 NOT_YET_RECRUITING
Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities
University of California, San Diego
2026-05-15 PHASE2
NCT07760506 NOT_YET_RECRUITING
Healthy Aging; Inflammaging; Metabolic Health; Quercetin; Coenzyme Q10
Applied Science & Performance Institute
2026-08
NCT06515184 RECRUITING
Gulf War Syndrome; Persian Gulf Syndrome; Mitochondrial Disorder, Respiratory Chain
University of California, San Diego
2024-09-13 PHASE3
NCT07748130 NOT_YET_RECRUITING
Mitochondrial Diabetes
The 95th Hospital of Putian,Putian, Fujian, China
2026-09
NCT06597682 NOT_YET_RECRUITING
Post-acute Sequelae of SARS-COV-2 Infection
Huashan Hospital
2025-03
NCT05422534 RECRUITING
End Stage Renal Disease
Vanderbilt University Medical Center
2023-06-01 PHASE3
NCT06620523 RECRUITING
Renal Failure; Coronary Artery Disease; Surgery; Surgery-Complications
George Washington University
2024-07-18 PHASE2
NCT07792005 NOT_YET_RECRUITING
Cardiovascular Disease (CVD); Elevated Cardiovascular Risk; Endothelial Dysfunction
Hospital Pengajar Universiti Putra Malaysia
2026-10
NCT07476443 NOT_YET_RECRUITING
Nephrotoxicity
Ain Shams University
2026-04-20 PHASE2; PHASE3
NCT07260773 NOT_YET_RECRUITING
Ovarian Response
Tang-Du Hospital
2026-07
NCT07677826 RECRUITING
Depigmentation Treatment; Depigmentation
Al-Azhar University
2026-03-02
NCT07772336 NOT_YET_RECRUITING
Frailty; Aging; Mitochondria Health; Skin Aging; Mitochondrial Dysfunction
University Medical Centre Ljubljana
2026-09
NCT07502924 RECRUITING
Muscle Health; Muscle Strength; Body Composition
Lindenwood University
2025-03-03
NCT05942027 RECRUITING
Chronic Kidney Diseases
Tanta University
2023-07-15 PHASE4
NCT07530250 COMPLETED
CoQ10 Blood Levels
Midwest Center for Metabolic and Cardiovascular Research
2026-05-18
NCT07252518 RECRUITING
Asthenozoospermia
Mst.Sumyara Khatun
2025-10-01
NCT07771153 COMPLETED
Oligospermia
Mst.Sumyara Khatun
2025-07-01
NCT07255079 COMPLETED
Pharmacokinetic Parameters; Bioavailability Heathy Volunteers
3i Solutions
2026-04-03
NCT07317440 NOT_YET_RECRUITING
Community Acquired Pneumonia
Tanta University
2025-12-31
NCT07029360 RECRUITING
Pregnancy; Periodontal Disease; Gingivitis; Dental Plaque; Probiotics; Coenzyme Q10; Microbiota
University of Pavia
2025-07-01
NCT06419335 ACTIVE_NOT_RECRUITING
Crohn Disease; Healthy
University of Pennsylvania
2024-07-20 EARLY_PHASE1
NCT07331935 RECRUITING
Oral Leukoplakia
Alexandria University
2025-11-25
NCT06743802 RECRUITING
Postoperative Pain
The Second Affiliated Hospital of Chongqing Medical University
2025-01-09 PHASE4
NCT07045246 NOT_YET_RECRUITING
Coenzyme Q10; Alveolar Cleft Grafting
Fayoum University
2025-07-15
NCT06040905 COMPLETED
Mild Cognitive Impairment; Alzheimer Disease; Hyperglycemia; Pre-sarcopenia
Chung Shan Medical University
2024-01-24
NCT07307911 COMPLETED
Breast Cancer
Damanhour University
2025-11-10 PHASE2
NCT07455890 COMPLETED
Asthenozoospermia
Mst.Sumyara Khatun
2024-07-01
NCT04444349 RECRUITING
Cardiovascular Disease
Nanjing Medical University
2021-02-01
NCT04972552 ACTIVE_NOT_RECRUITING
Kidney Transplantation
University of California, San Francisco
2021-11-15
NCT06361680 UNKNOWN
Type 1 Diabetes Mellitus
Assiut University
2024-10-30 EARLY_PHASE1
NCT06308497 ENROLLING_BY_INVITATION
Periodontal Diseases; Pregnancy Related
University of Pavia
2024-03-10
NCT06640465 COMPLETED
Wellness; Health
OvationLab
2024-10-12 PHASE2; PHASE3
NCT06089395 UNKNOWN
Poor Ovarian Response
Shi Yun
2024-06-01 EARLY_PHASE1
NCT06619249 UNKNOWN
Health Knowledge, Attitudes, Practice
Gdansk University of Physical Education and Sport
2024-08-23 PHASE4
NCT05984745 RECRUITING
Fatty Liver; NAFLD
Ain Shams University
2023-10-31 PHASE2
NCT06856447 RECRUITING
Colorectal Cancer
toqa saad mohammed mohammed
2024-06-01 PHASE1
NCT06659406 UNKNOWN
Polycystic Ovarian Syndrome (PCOS)
University of Faisalabad
2025-01-01
NCT06570811 COMPLETED
Breast Cancer; Chemotherapeutic Toxicity
Damanhour University
2024-08-01 PHASE2
NCT05873673 ACTIVE_NOT_RECRUITING
Cyst, Jaw
Fayoum University
2023-06-11 PHASE2
NCT06506630 UNKNOWN
Metabolic Syndrome; Cardiovascular Diseases
Tian Zezhong
2023-09-11
NCT06405204 UNKNOWN
IVF
Beni-Suef University
2024-06-30 PHASE3
NCT06736366 COMPLETED
Coenzyme Q Deficiency
University of Primorska
2024-12-05
NCT07303088 COMPLETED
Oxidative Stress Response; Hemodialysis; End Stage Kidney Disease (ESRD)
University of Sfax
2024-06-17
NCT07096557 COMPLETED
Systemic Lupus Erythematosus
Ain Shams University
2024-01-01 PHASE2
NCT05500742 UNKNOWN
Aging
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2022-07-22
NCT06429345 UNKNOWN
Contrast-induced Nephropathy
Ain Shams University
2024-06-15 PHASE4
NCT06452134 UNKNOWN
Molar, Third; Temporomandibular Joint Disorders; Dry Socket; Coenzyme Q10
Zahra Nejati
2024-07 PHASE4
NCT05945160 WITHDRAWN
Vestibular Function Disorder
The University of Texas Health Science Center at San Antonio
2024-01 EARLY_PHASE1
NCT06342856 UNKNOWN
Infertility Unexplained; Oligospermia
Ain Shams University
2023-06-15 EARLY_PHASE1
NCT03831425 WITHDRAWN
Prader-Willi Syndrome
The Hospital for Sick Children
2023-06-01 PHASE2
NCT06373848 ENROLLING_BY_INVITATION
Periodontal Diseases
Islamic Azad University, Sanandaj
2024-03-20
NCT06661018 COMPLETED
ST Segment Elevation Myocardial Infarction (STEMI); Coenzyme Q10
Universitas Diponegoro
2024-01-28
NCT06358963 UNKNOWN
Periodontal Diseases
Amirhossein Farahmand
2024-02-20
NCT04286178 COMPLETED
Myositis, Juvenile
The Hospital for Sick Children
2021-04-06
NCT05731596 UNKNOWN
Nonalcoholic Steatohepatitis
Tanta University
2023-06 PHASE3
NCT05471453 COMPLETED
Dietary Supplements
Kaohsiung Veterans General Hospital.
2022-03-02
NCT05653895 COMPLETED
PCOS
Khyber Medical University Peshawar
2022-12-07
NCT04999488 Withdrawn
Sarcopenia
AdventHealth Translational Research Institute
2023-12 Early Phase 1
NCT05871086 UNKNOWN
Juvenile Idiopathic Arthritis
Nourhan Elsherif
2023-05-01 PHASE2; PHASE3
NCT07537283 COMPLETED
Epilepsy; Drugs Resistance
National Cheng-Kung University Hospital
2023-02-07
NCT05984745 Not yet recruiting
Fatty Liver|NAFLD
Ain Shams University
2023-09 Phase 2
NCT05941910 UNKNOWN
Non-Alcoholic Fatty Liver Disease
Attikon Hospital
2023-04-01 PHASE2
NCT05412888 NOT_YET_RECRUITING
Ischemic Preconditioning; Coenzyme Q Deficiency; Exercise Training
Medical University of Gdansk
2023-03-01
NCT05680857 COMPLETED
Healthy
USMARI Research & Innovation Centre
2022-12-01
NCT05293132 COMPLETED
Sepsis
Ain Shams University
2022-02-01 PHASE2; PHASE3
NCT05711810 COMPLETED
Severe Acute Respiratory Syndrome-related Coronavirus; Renal Dialysis; Vaccines; Myocarditis Allergic; Infection Viral
Yang I. Pachankis
2023-01-02 PHASE4
NCT03113994 TERMINATED
Spinal Cord Injuries; Osteoporosis; Metabolic Syndrome
Dr. B. Catharine. Craven
2018-02-26 PHASE2
NCT05616000 COMPLETED
Infertility
Khyber Medical University Peshawar
2022-08-06 PHASE2
NCT06151171 COMPLETED
Coenzyme Q10 Pharmacokinetics
Factors Group of Nutritional Companies Inc.
2022-03-01
NCT05847257 COMPLETED
Male Reproductive Problem; Infertility, Male
Al-Mustansiriyah University
2021-12-01 PHASE2
NCT04487652 COMPLETED
Gingival Recession
University of Bern
2020-09-01
NCT05170893 COMPLETED
Hemodialysis
Ain Shams University
2022-01-17
NCT05272228 COMPLETED
Coenzyme Q Deficiency
University of Primorska
2022-03-09
NCT03611530 TERMINATED
Open Angle Glaucoma
Mario Negri Institute for Pharmacological Research
2017-09-04
NCT04960215 COMPLETED
Covid19; Long Term Covid19
Aarhus University Hospital
2021-05-25 PHASE2
NCT04091698 UNKNOWN
Oral Lichen Planus
Cairo University
2019-10-01 PHASE1
NCT04445779 UNKNOWN
Acute Kidney Injury; Acute Kidney Failure
Clinical Hospital Center, Split
2020-07-15
NCT04038034 UNKNOWN
Glaucoma, Open-Angle
VISUfarma SpA
2019-09-01
NCT05178225 COMPLETED
COVID-19 Respiratory Infection
Comenius University
2021-05-01
NCT04780074 COMPLETED
Bioavailability of Coenzyme Q10
Institute of Nutrition, Slovenia (Nutris)
2021-02-28
NCT03579693 COMPLETED
Chronic Kidney Disease; Sarcopenia; Frailty
University of Washington
2018-11-14 PHASE2
NCT03133793 COMPLETED
Heart Failure, Diastolic
University of Kansas Medical Center
2018-02-05 PHASE2
NCT02865460 COMPLETED
Gulf War Illness; Chronic Fatigue; Ubiquinol; Coenzyme Q10
VA Office of Research and Development
2017-07-24 PHASE3
NCT04302532 COMPLETED
Coenzyme q10
Karachi Medical and Dental College
2020-07-01 PHASE4
NCT04035525 UNKNOWN
Healthy
Mélanie Plourde
2020-03-04
NCT03968640 WITHDRAWN
Multiple Organ Failure
American Burn Association
2018-07-01 PHASE3
NCT03186027 COMPLETED
Chronic Fatigue Syndrome
Hospital Universitari Vall d'Hebron Research Institute
2017-06-28
NCT03961087 UNKNOWN
Hepatic Encephalopathy; Coenzyme Q10; Intellectual Functioning Disability
Zagazig University
2019-05-23
NCT03190044 UNKNOWN
Migraine Disorders
University of Roma La Sapienza
2017-06-06
NCT03576911 UNKNOWN
Schizophrenia; Schizoaffective Disorder
University of Dublin, Trinity College
2016-11
NCT03321110 COMPLETED
Athlete
Chung Shan Medical University
2017-12-01
NCT06391606 COMPLETED
Hypercholesterolemia; Physical Performance
University of Bologna
2018-10-01
NCT03811756 COMPLETED
Dermis Density; Trans Epidermal Water Loss (TEWL); Skin Hydration; Wrinkles; Dermis Thickness
VIST - Faculty of Applied Sciences
2018-10-15
NCT03850561 COMPLETED
Male Infertility
University of Sumer
2018-06-01
NCT03834831 COMPLETED
Male Infertility
University of Sumer
2018-06-01
NCT05128292 COMPLETED
Myalgic Encephalomyelitis
Hospital Universitari Vall d'Hebron Research Institute
2018-01-01
NCT03819491 COMPLETED
Male & Female Healthy Volunteers
VISUfarma SpA
2018-06-22 PHASE1
NCT03213769 UNKNOWN
Oral Aphthous Ulcer
Cairo University
2017-07
NCT03893864 COMPLETED
Coenzyme Q10; Oxidative Stress; Aging
Centre d'Alt Rendiment
2018-03-01 PHASE1
NCT02119117 COMPLETED
Mitochondrial DNA; Aneuploidy
Reproductive Endocrinology Associates of Charlotte
2014-04
NCT03104998 WITHDRAWN
Idiopathic Infertility
PharmEvo Pvt Ltd
2017-08-01 PHASE4
NCT03111433 COMPLETED
Diabetes Mellitus, Type 1
Ain Shams University
2017-03-19 PHASE2
NCT03020680 COMPLETED
Absorption
Tufts University
2016-04-01 PHASE1
NCT01126697 COMPLETED
Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Limb Girdle Muscular Dystrophy
Cooperative International Neuromuscular Research Group
2010-02 PHASE2; PHASE3
NCT02010164 UNKNOWN
Reproductive Physiological Phenomena
Hadassah Medical Organization
2016-12
NCT03284814 COMPLETED
Bioavailability of Coenzyme Q10
Institute of Nutrition, Slovenia (Nutris)
2017-08-29
NCT02333305 COMPLETED
Ataxia-oculomotor Apraxia 1
Assistance Publique - Hôpitaux de Paris
2013-06 PHASE3
NCT02407548 COMPLETED
Dyslipidemia
Sun Yat-sen University
2015-07 PHASE3
NCT02251626 UNKNOWN
Burn Injury
Massachusetts General Hospital
2014-04 EARLY_PHASE1
NCT02486796 TERMINATED
Quality of Life
Midwestern Regional Medical Center
2016-02-19 PHASE1; PHASE2
NCT02622672 COMPLETED
Diabetes
Yeh
2016-01-04 PHASE2; PHASE3
NCT02218476 UNKNOWN
Coenzyme Q10 on Athero-thrombosis in APS Patients
Maimónides Biomedical Research Institute of Córdoba
2013-09
NCT03074344 COMPLETED
Dry Eye Syndrome
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
2016-05
NCT02353650 UNKNOWN
Tinnitus
University Hospital, Antwerp
2014-11
NCT01032993 COMPLETED
Pain; Weakness; Cramps; Myalgia or Myositis Nos; HMG COA Reductase Inhibitor Adverse Reaction
Catherine Buettner
2009-12 PHASE2; PHASE3
NCT01964001 COMPLETED
Hepatocellular Carcinoma.
Taichung Veterans General Hospital
2014-01 PHASE2; PHASE3
NCT02042482 UNKNOWN
Myelodysplastic Syndrome
Kaplan Medical Center
2013-05 PHASE2; PHASE3
NCT02315651 UNKNOWN
Attention Deficit Hyperactivity Disorder
Rabin Medical Center
2015-01
NCT02415114 COMPLETED
CoQ10 Blood Levels; CoQ10 Blood Levels With Statin Use
KGK Science Inc.
2015-03 PHASE1
NCT02604641 COMPLETED
Wrinkles; Ageing; Photoprotection
VIST - Faculty of Applied Sciences
2014-10
NCT00608881 TERMINATED
Huntington's Disease
Massachusetts General Hospital
2008-03 PHASE3
NCT01659788 UNKNOWN
Ovarian Function at Advanced Reproductive Age
Hadassah Medical Organization
2012-09
NCT00997269 COMPLETED
Pain; Soreness; Weakness; Fatigue
Stony Brook University
2009-09
NCT01948063 COMPLETED
Sepsis
Beth Israel Deaconess Medical Center
2012-10 PHASE2
NCT01819701 COMPLETED
Coronary Artery Disease
Taichung Veterans General Hospital
2013-01 PHASE2; PHASE3
NCT01925937 UNKNOWN
Congestive Heart Failure
Isfahan University of Medical Sciences
2013-06
NCT01148836 COMPLETED
Pulmonary Arterial Hypertension
The Cleveland Clinic
2010-01
NCT01408680 COMPLETED
Oxidative Stress; Inflammation; Endothelial Dysfunction
University of Washington
2011-11
NCT01140308 UNKNOWN
Statin Myopathy
Hartford Hospital
2009-09
NCT00382824 COMPLETED
Progressive Supranuclear Palsy
Lahey Clinic
2006-09
NCT01660191 COMPLETED
Hypercholesterolemia
University of Kansas Medical Center
2011-12 PHASE4
NCT00432744 COMPLETED
Mitochondrial Diseases
University of Florida
2007-01 PHASE3
NCT01424761 COMPLETED
Coronary Artery Disease
Taichung Veterans General Hospital
2011-08 PHASE2; PHASE3
NCT02381964 COMPLETED
Metabolic Processes
Northumbria University
2012-03
NCT01910766 COMPLETED
Polycystic Ovary Syndrome
Mansoura University
2010-01
NCT02063126 COMPLETED
Chronic Fatigue Syndrome
Hospital Universitari Vall d'Hebron Research Institute
2013-01 PHASE2; PHASE3
NCT00541164 COMPLETED
Charcot Marie Tooth Disease
Memorial Medical Center
2007-09 PHASE1; PHASE2
NCT01048385 TERMINATED
Aneuploidy; Pregnancy; Miscarriage
University of Toronto
2009-12
NCT01892176 COMPLETED
Parkinson Disease
National University Hospital, Singapore
2012-06 PHASE2; PHASE3
NCT00891917 WITHDRAWN
Down Syndrome
Children's Hospital Medical Center, Cincinnati
2005-01 PHASE2
NCT00976131 COMPLETED
Breast Cancer
Columbia University
2009-09 PHASE1
NCT00716612 COMPLETED
Statin Induced Myalgia
Hadassah Medical Organization
2009-01
NCT01390389 COMPLETED
Bipolar Depression
Mclean Hospital
2011-07
NCT00920699 COMPLETED
Huntington's Disease
Johns Hopkins University
2010-02 PHASE2
NCT01319110 COMPLETED
Cardiac Arrest; Sudden Cardiac Arrest
Beth Israel Deaconess Medical Center
2011-02 PHASE2
NCT00893724 UNKNOWN
Neovascular Age-related Macular Degeneration; Diabetic Macular Edema
Mid-Atlantic Retina Consultations, Inc.
2009-06
NCT00740714 TERMINATED
Parkinson Disease
Weill Medical College of Cornell University
2008-12 PHASE3
NCT01011348 COMPLETED
Gulf War Illness
University of California, San Diego
2008-07
NCT01026311 COMPLETED
Muscle Weakness; Myalgia; Side Effects of Statins
Richard Deichmann, MD
2009-11 PHASE4
NCT00308113 TERMINATED
Duchenne Muscular Dystrophy
Cooperative International Neuromuscular Research Group
2007-04 PHASE3
NCT00908297 COMPLETED
Cardiovascular Disease; End Stage Renal Disease; Atherosclerosis; Oxidative Stress
University of Washington
2010-02
NCT00860847 COMPLETED
Coronary Atherosclerosis; Coronary Artery Calcification; Coronary Stenosis
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
2009-05 PHASE3
NCT00720369 COMPLETED
Bipolar Depression
Mclean Hospital
2008-07
NCT01443780 COMPLETED
Cardiovascular Mortality; Cardiac Function
University Hospital, Linkoeping
2003-01
NCT00718796 COMPLETED
Cardiovascular Disease
The Canadian College of Naturopathic Medicine
2008-04 PHASE3
NCT00096356 COMPLETED
Breast Cancer; Fatigue
Wake Forest University Health Sciences
2004-08-27 PHASE1
NCT00957216 COMPLETED
Sporadic Ataxia
The University of Texas Medical Branch, Galveston
2008-04 PHASE1
NCT02012322 COMPLETED
Age Related Symptoms; Age Related Quality of Life Issues
University of California, San Diego
2008-11
NCT00327756 WITHDRAWN
Bipolar Affective Disorder; Depression
National Institute of Mental Health (NIMH)
2006-05 PHASE2
NCT01163500 COMPLETED
Coronary Artery Disease
Taichung Veterans General Hospital
2008-07 PHASE2; PHASE3
NCT00590408 TERMINATED
Statin-associated Myalgia
Creighton University
2006-03 PHASE4
NCT02115581 COMPLETED
Dilated Cardiomyopathy
University of Tehran
2006-09 PHASE4
NCT00243932 COMPLETED
Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease
Columbia University
2005-04 PHASE2
NCT00076492 COMPLETED
Parkinson Disease
University of Rochester
2004-01 PHASE2
NCT00180037 COMPLETED
Parkinson's Disease
Technische Universität Dresden
2003-09 PHASE3
NCT00703482 COMPLETED
Patients With Type 2 Diabetes
Solvay Pharmaceuticals
2003-05 PHASE2
NCT00328874 COMPLETED
Progressive Supranuclear Palsy
German Parkinson Study Group (GPS)
2006-05 PHASE2
NCT00307996 COMPLETED
Chronic Renal Failure; Hemodialysis
University of Shizuoka
2004-03 PHASE4
NCT00247026 WITHDRAWN
Myelodysplastic Syndrome
Hadassah Medical Organization
2007-04 PHASE1; PHASE2
NCT00532571 COMPLETED
Progressive Supranuclear Palsy; Neurological Disorders
Lahey Clinic
2004-01 PHASE2; PHASE3
NCT00878124 TERMINATED
Poor Ovarian Response
University of Toronto
2009-06
NCT00300937 COMPLETED
Preeclampsia
Teran, Enrique, MD, PhD
2004-07 PHASE3
NCT00033189 COMPLETED
Muscular Dystrophy, Duchenne
Cooperative International Neuromuscular Research Group
2001-09 PHASE2
NCT00004731 COMPLETED
Parkinson's Disease
National Institute of Neurological Disorders and Stroke (NINDS)
1998-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-19)

Check the Coenzyme Q10 (CoQ10) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Coenzyme Q10 functions as an essential lipid-soluble electron carrier within the mitochondrial respiratory chain, shuttling electrons between complex I/II and complex III to facilitate oxidative phosphorylation and cellular adenosine triphosphate production. By maintaining mitochondrial bioenergetics and reducing reactive oxygen species, it protects cellular membranes against oxidative damage and sustains metabolic capacity, supporting its therapeutic application in clinical trials for cardiovascular, metabolic, and neurodegenerative diseases.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.