Standard
In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.
According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.
In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.
International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.
Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.
Click on the specific product, view the latest prices of the products, information, serving information
- Structure:
- Chemical Name:
- Nicorandil Impurity 13
- CAS:
- 19416-51-4
- MF:
- C9H11NO3
- Chemical Name:
- Rosuvastatin Impurity 51
- Structure:
- Chemical Name:
- Silodosin Impurity 3
- CAS:
- 1402161-34-5
- MF:
- C29H31N3O2
- Chemical Name:
- Tenofovir Impurity 61
- Chemical Name:
- Ticagrelor Impurity 70
- CAS:
- 1824025-11-7
- Structure:
- Chemical Name:
- Topiroxostat Impurity 21
- CAS:
- 2044704-74-5
- MF:
- C13H7N5O
- Structure:
- Chemical Name:
- Mirabegron Impurity 17
- CAS:
- 1684452-84-3
- MF:
- C31H32N8O4S3
- Chemical Name:
- Afatinib Impurity 24
- Structure:
- Chemical Name:
- Amifostine Impurity 8
- CAS:
- 66487-25-0
- MF:
- C5H10N2O
- Chemical Name:
- Bendamustine Impurity 33
- Chemical Name:
- Bendamustine Impurity 38
- Structure:
- Chemical Name:
- Ciprofloxacin Impurity 4
- MF:
- C17H18FN3O3
- Chemical Name:
- Dapagliflozin Impurity 29
- Chemical Name:
- Erlotinib Impurity 52
- Chemical Name:
- Etoposide Impurity 3
- Chemical Name:
- Nintedanib Impurity 29
- Chemical Name:
- Olaparib Impurity 23
- Chemical Name:
- Oseltamivir Impurity 19
- Structure:
- Chemical Name:
- Rocuronium bromide Impurity 30
- CAS:
- 56240-11-0
- MF:
- C19H26O
- Chemical Name:
- Rocuronium Bromide Impurity 38
- Structure:
- Chemical Name:
- S-Silodosin
- CAS:
- 2182279-45-2
- MF:
- C25H32F3N3O4
- Structure:
- Chemical Name:
- Terazosin EP Impurity D
- CAS:
- 102714-74-9
- MF:
- C15H19N5O3
- Structure:
- Chemical Name:
- Apremilast Impurity FA
- CAS:
- 2077897-94-8
- MF:
- C21H22N2O7S
- Chemical Name:
- Atracurium Impurity S
- Chemical Name:
- Mirabegron Impurity MADT
- Chemical Name:
- Palbociclib Impurity 30
- Structure:
- Chemical Name:
- Parecoxib Impurity Q
- CAS:
- 1373038-58-4
- MF:
- C16H14N2O3S
- Chemical Name:
- Ropivacaine Impurity 30
- Chemical Name:
- Ropivacaine Impurity 39
- Chemical Name:
- Sugammadex sodium Org46643 Impurity
- Chemical Name:
- Afatinib impurity 27
- Structure:
- Chemical Name:
- Butyphthalide impurity 41
- CAS:
- 1379166-79-6
- MF:
- C9H10O3
- Chemical Name:
- Butyphthalide impurity 47
- Chemical Name:
- Dapoxetine impurity 19
- Chemical Name:
- Empagliflozin Impurity KHC
- Structure:
- Chemical Name:
- Febuxostat Impurity 70
- CAS:
- 2418591-43-0
- MF:
- C16H16N2O3S
- Chemical Name:
- Febuxostat Impurity 92
- Structure:
- Chemical Name:
- Fluconazole Impurity N
- MF:
- C13H12F2N6O
- Structure:
- Chemical Name:
- Ibrutinib Impurity 25
- CAS:
- 2052279-48-6
- MF:
- C28H28N6O4
- Structure:
- Chemical Name:
- Ipratropium Bromide Impurity 2
- MF:
- C20H29Br2NO3
- Chemical Name:
- Lenvatinib Impurity 21
- Chemical Name:
- Moxifloxacin Impurity 45
- Chemical Name:
- Olaparib Impurity O
- Chemical Name:
- Olsalazine Impurity D
- Chemical Name:
- Parecoxib sodium Impurity 34
- Structure:
- Chemical Name:
- Tofacitinib Impurity 19
- CAS:
- 2056104-91-5
- MF:
- C27H31N5O2S
- Chemical Name:
- Topiroxostat Impurity 29
- Structure:
- Chemical Name:
- Vildagliptin Impurity ZA6
- CAS:
- 2246354-69-6
- MF:
- C17H23N3O2
- Chemical Name:
- Nintedanib Impurity O
- Structure:
- Chemical Name:
- Palonosetron Impurity TM1-SS
- CAS:
- 1260610-96-5
- MF:
- C15H23ClN2
- Structure:
- Chemical Name:
- Amoxicillin EP impurity P
- MF:
- C16H19N3O5S
- Chemical Name:
- Eltrombopag Impurity 3
- Chemical Name:
- Saxagliptin Impurity 5 (Epoxy saxaglliptin)
- Structure:
- Chemical Name:
- (1r,4r)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride
- CAS:
- 101900-44-1
- MF:
- C13H20BrClN2O
- Chemical Name:
- (2S,4S)-5-(Biphenyl-4-yl)-4-[(3-carboxypropionyl)amino]-2-methylpentanoic acid ethyl ester,calcium salt(2:1)
- Structure:
- Chemical Name:
- Diltiazem impurity
- CAS:
- 115992-91-1
- MF:
- C17H18N2O3S
- Structure:
- Chemical Name:
- Raloxifene EP IMpurity
- CAS:
- 1700655-64-6
- MF:
- C13H15ClN2O2S
- Chemical Name:
- Parecoxib Impurity M
- Structure:
- Chemical Name:
- (-)-Lyoniresinol 9'-O-glucoside
- CAS:
- 143236-02-6
- MF:
- C28H38O13
- Structure:
- Chemical Name:
- Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-[4-(4-ethyl-1-piperazinyl)phenyl]-5,6,7,8,9,10-hexahydro-
- CAS:
- 1648791-23-4
- MF:
- C29H43N5
- Chemical Name:
- Linagliptin Impurity O
- Chemical Name:
- Linagliptin Impurity T
- Structure:
- Chemical Name:
- (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzamide
- MF:
- C18H22FN5O3
- Chemical Name:
- Apremilast Impurity 2
- Chemical Name:
- Etoricoxib Impurity 16
- Chemical Name:
- Ibrutinib Impurity 2
- Chemical Name:
- Mirabegron Impurity 14
- Structure:
- Chemical Name:
- Vonoprazan Impurity 1
- CAS:
- 881732-90-7
- MF:
- C17H17N3O2S
- Structure:
- Chemical Name:
- Atenolol EP Impurity
- MF:
- C14H22N2O3
- Chemical Name:
- Cinacalcet Impurity 20
- Chemical Name:
- Dapagliflozin Impurity 11
- Structure:
- Chemical Name:
- 1-(7,8-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride
- CAS:
- 1822601-94-4
- MF:
- C12H15N
- Structure:
- Chemical Name:
- Sofosbuvir metabolites
- CAS:
- 1859162-80-3
- MF:
- C16H18FN2O8P
- Structure:
- Chemical Name:
- 1,3,5,7-tetrahydroxyadamantane
- CAS:
- 16104-28-2
- MF:
- C10H16O4
- Chemical Name:
- Cabozantinib Impurity E
- Chemical Name:
- Loxoprofen Impurity I
- Chemical Name:
- Sofosbuvir Impurity22
- Structure:
- Chemical Name:
- Donepezil Impurity-OH
- CAS:
- 148517-82-2
- MF:
- C11H12O4
- Structure:
- Chemical Name:
- 1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-(hydroxyamino)pyrimidin-2-one
- CAS:
- 13491-41-3
- MF:
- C9H13N3O6
- Structure:
- Chemical Name:
- 1-(2-amino-4,5-dimethoxyphenyl)ethan-1-one
- CAS:
- 1071574-51-0
- MF:
- C10H13NO3
- Structure:
- Chemical Name:
- (+)-epipinoresinol-4-O-β-D-glucoside
- CAS:
- 74983-66-7
- MF:
- C26H32O11
- Structure:
- Chemical Name:
- 2-[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylthio-1H-benzimidazole
- CAS:
- 103577-40-8
- MF:
- C16H14F3N3OS
- Structure:
- Chemical Name:
- Ethyl (3E)-3-(2-phenylhydrazin-1-ylidene)butanoate
- CAS:
- 6078-46-2
- MF:
- C12H16N2O2
- Structure:
- Chemical Name:
- 1-(5,6-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride
- CAS:
- 1824506-44-6
- MF:
- C12H15N
- Structure:
- Chemical Name:
- (S)-4-(4-((3-amino-2-hydroxypropyl)amino)phenyl)morpholin-3-one hydrochloride
- CAS:
- 1403383-55-0
- MF:
- C13H20ClN3O3
- Structure:
- Chemical Name:
- Terbutaline Impurity
- CAS:
- 882066-15-1
- MF:
- C33H35NO3.H2O4S
- Structure:
- Chemical Name:
- Bis(4-fluorobenzyl)aMine
- CAS:
- 646051-52-7
- MF:
- C14H13F2N
- Structure:
- Chemical Name:
- ethyl 1-cyclopropyl-6-fluoro-7-((4aS,7aS)-hexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl)-8-hydroxy-4-oxo-1,4-dihydroquinoline-3-carboxylate
- MF:
- C22H26FN3O4
- Structure:
- Chemical Name:
- Matairesinol monoglucoside
- CAS:
- 34446-06-5
- MF:
- C26H32O11
- Structure:
- Chemical Name:
- Apremilast
- CAS:
- 1384967-20-7
- MF:
- C20H20N2O7S
- Structure:
- Chemical Name:
- Pramipexole Impurity 30
- CAS:
- 1802051-36-0
- MF:
- C13H24ClN3S
- Structure:
- Chemical Name:
- NZWJKTHFNLHUJO-NWZSJJIMSA-N
- CAS:
- 1422954-12-8
- MF:
- C22H26FN3O5S
- Structure:
- Chemical Name:
- LAT-NET
- CAS:
- 607351-44-0
- MF:
- C25H39NO4
- Structure:
- Chemical Name:
- N,N-(ethane-1,2-diyl)bis(4-methyl-N-(3-((4-methylphenyl)sulfonamido)propyl)benzenesulfonamide)
- CAS:
- 74676-47-4
- MF:
- C36H46N4O8S4
- Structure:
- Chemical Name:
- L-GLUCONO-1,5-LACTONE
- CAS:
- 52153-09-0
- MF:
- C6H10O6
- Structure:
- Chemical Name:
- C-Desmethyl Atenolol
- CAS:
- 1797116-92-7
- MF:
- C13H20N2O3
- Structure:
- Chemical Name:
- Arthromerin B
- CAS:
- 31049-08-8
- MF:
- C21H22O11
- Structure:
- Chemical Name:
- Fenofibric Acid 1-Carboxyl-1-methylethyl Ester
- CAS:
- 1797121-54-0
- MF:
- C21H21ClO6
- Structure:
- Chemical Name:
- 2-Chloro-4'-fluorobenzophenone
- CAS:
- 1806-23-1
- MF:
- C13H8ClFO