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.
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- Chemical Name:
- Moxifloxacin Impurity 49
- Chemical Name:
- Olsalazine Impurity B
- Chemical Name:
- Parecoxib sodium Impurity 32
- Chemical Name:
- Rosuvastatin Impurity 39
- Chemical Name:
- Tofacitinib Impurity 95
- Chemical Name:
- Vildagliptin Impurity ZA4
- Structure:
- Chemical Name:
- (E)-4-(2-(1-(m-tolyl)ethylidene)hydrazinyl)benzenesulfonamide
- MF:
- C15H17N3O2S
- Structure:
- Chemical Name:
- 5,6-Dehydro-Tigecycline
- CAS:
- 1633815-62-9
- MF:
- C29H37N5O8
- Structure:
- Chemical Name:
- CIS-1,2-BIS(AMINOMETHYL)CYCLOBUTANE
- CAS:
- 15286-88-1
- MF:
- C6H14N2
- Structure:
- Chemical Name:
- O-DesmethylApixabanSulphateNa
- CAS:
- 1118765-14-2
- MF:
- C24H23N5O7S
- Structure:
- Chemical Name:
- Ethylmethyl-carbamic chloride
- CAS:
- 42252-34-6
- MF:
- C4H8ClNO
- Structure:
- Chemical Name:
- Cisatracurium-20-methyl Dibenzenesulfonate
- CAS:
- 1193104-85-6
- MF:
- C60H79N2O15S+
- Structure:
- Chemical Name:
- [R-(R*,S*)]-(-)-N-(1-PHENYLETHYL)-1-AZABICYCLO[2.2.2]OCTAN-3-AMINE DIHYDROCHLORIDE
- CAS:
- 128311-06-8
- MF:
- C15H24Cl2N2
- Structure:
- Chemical Name:
- GURKHSYORGJETM-MGDILKBHSA-N
- CAS:
- 1992961-26-8
- MF:
- C33H39ClN4O6
- Structure:
- Chemical Name:
- DVCUGHHGLKCBMT-QVDQXJPCSA-N
- CAS:
- 1356353-76-8
- MF:
- C15H24N6O6
- Structure:
- Chemical Name:
- (1R,5S)-1-phenyl-3-oxabicyclo[3.1.0]hexan-2-one
- CAS:
- 96847-52-8
- MF:
- C11H10O2
- Structure:
- Chemical Name:
- (1R,1'R,2S,2'S)-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-Isoquinolinium Benzenesulfonate
- CAS:
- 96946-46-2
- MF:
- C59H77N2O15S+
- Structure:
- Chemical Name:
- (2R,3R,4R,5R)-2-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-3-yl acetate
- MF:
- C10H14N4O6
- Structure:
- Chemical Name:
- Ropivacaine-iPr-R
- CAS:
- 1050482-18-2
- MF:
- C17H26N2O
- Structure:
- Chemical Name:
- Demiditraz IMpurity
- CAS:
- 944268-66-0
- MF:
- C20H22N2O
- Structure:
- Chemical Name:
- AcarBose EP Impurity B
- CAS:
- 1220983-54-9
- MF:
- C26H43NO17
- Chemical Name:
- Alogliptin Impurity 17
- Structure:
- Chemical Name:
- Aprepitant Impurity 15
- CAS:
- 1447693-83-5
- MF:
- C20H19ClF7NO2
- Structure:
- Chemical Name:
- Betamethasone EP Impurity H
- CAS:
- 185613-71-2
- MF:
- C22H29FO5
- Structure:
- Chemical Name:
- Blonanserin Impurity 10
- CAS:
- 132810-87-8
- MF:
- C23H30ClN3
- Chemical Name:
- Blonanserin impurity G
- Chemical Name:
- Cefodizime Impurity 5
- Chemical Name:
- Clindamycin Impurity 4
- Structure:
- Chemical Name:
- Doxofylline Impurity 4
- CAS:
- 2095554-12-2
- MF:
- C11H16N4O5
- Structure:
- Chemical Name:
- Eltrombopag Impurity 1
- CAS:
- 1246929-02-1
- MF:
- C25H23N5O3
- Chemical Name:
- Everolimus impurity A
- Chemical Name:
- Fosaprepitant Impurity 13
- Chemical Name:
- Gefitinib Impurity J
- Chemical Name:
- Isavuconazole Impurity 23
- Chemical Name:
- Isavuconazole Impurity 29
- Chemical Name:
- Isavuconazole Impurity 7
- Structure:
- Chemical Name:
- Lercanidipine Impurity 6
- CAS:
- 786625-22-7
- MF:
- C37H43N3O6
- Chemical Name:
- Linagliptin Impurity 43
- Chemical Name:
- MiraBegron Impurity A
- Chemical Name:
- Moxifloxacin Impurity 15
- Chemical Name:
- Moxifloxacin Impurity 32
- Structure:
- Chemical Name:
- Nifedipine Impurity F
- CAS:
- 53055-15-5
- MF:
- C18H20N2O6
- Structure:
- Chemical Name:
- Olaparib Impurity 15
- CAS:
- 2250243-17-3
- MF:
- C24H25FN4O3
- Structure:
- Chemical Name:
- Olopatadine Impurity 4
- CAS:
- 55690-15-8
- MF:
- C18H18O5
- Structure:
- Chemical Name:
- 2,3,5,6-tetradeuterio-4-[5-[4-(hydroxymethyl)phenyl]-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide
- CAS:
- 1276524-56-1
- MF:
- C17H10D4F3N3O3S
- Structure:
- Chemical Name:
- 1,1-diphenylpropan-1-ol
- CAS:
- 5180-33-6
- MF:
- C15H16O
- Structure:
- Chemical Name:
- 12-ethyl-8-methyl-9-oxo-7-propionyl-9,11-dihydroindolizino[1,2-b]quinolin-2-yl [1,4'-bipiperidine]-1'-carboxylate
- CAS:
- 176515-52-9
- MF:
- C32H38N4O4
- Structure:
- Chemical Name:
- 4-amino-5-chloro-N-(1-propylpiperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide
- MF:
- C17H24ClN3O2
- Chemical Name:
- Ceftazidime Impurity D
- Chemical Name:
- Ceftazidime Sulfoxide Impurity
- Chemical Name:
- Tofacitinib Impurity Y
- Structure:
- Chemical Name:
- 5-amino-6-chloro-2-(propylthio)pyrimidin-4-ol
- MF:
- C7H10ClN3OS
- Chemical Name:
- Labetalol EP impurity G
- Structure:
- Chemical Name:
- 2-(2-NITROPHENYL)ETHANAMINE
- CAS:
- 33100-15-1
- MF:
- C8H10N2O2
- Structure:
- Chemical Name:
- 2-(4-HYDROXY-PHENYL)-4-METHYL-THIAZOLE-5-CARBOXYLIC ACID
- CAS:
- 886501-78-6
- MF:
- C11H9NO3S
- Structure:
- Chemical Name:
- BROMOSULBACTAM
- CAS:
- 75527-87-6
- MF:
- C8H10BrNO5S
- Structure:
- Chemical Name:
- (S)-PYRROLIDINE-2-CARBONITRILE
- CAS:
- 204387-53-1
- MF:
- C5H8N2
- Structure:
- Chemical Name:
- 1-(CHLOROACETYL)-L-PROLINE METHYL ESTER
- CAS:
- 38074-72-5
- MF:
- C8H12ClNO3
- Structure:
- Chemical Name:
- 1-(4-PIPERIDINYLCARBONYL)-4-PIPERIDINECARBOXYLIC ACID
- CAS:
- 96053-48-4
- MF:
- C12H20N2O3
- Structure:
- Chemical Name:
- 1-(3-PYRIDYL)ETHAN-1-ONE OXIME
- CAS:
- 5973-83-1
- MF:
- C7H8N2O
- Structure:
- Chemical Name:
- 1-(3,4,5-Trimethoxy-benzyl)-piperazinedihydrochloride
- CAS:
- 107049-57-0
- MF:
- C14H24Cl2N2O3
- Structure:
- Chemical Name:
- Sitagliptin N-Sulfate
- CAS:
- 940002-57-3
- MF:
- C16H15F6N5O4S
- Structure:
- Chemical Name:
- 1-Oxo Mirtazapine (Mirtazapine Impurity C)
- CAS:
- 191546-96-0
- MF:
- C17H17N3O
- Structure:
- Chemical Name:
- (3S,4S)-3-Hexyl-4-[(S)-2-hydroxytridecyl]-2-oxetanone
- CAS:
- 68711-40-0
- MF:
- C22H42O3
- Structure:
- Chemical Name:
- N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride_x000b_(Lidocaine Impurity E)
- CAS:
- 50295-20-0
- MF:
- C13H21ClN2O
- Structure:
- Chemical Name:
- ent-Cinacalcet Hydrochloride
- CAS:
- 694495-47-1
- MF:
- C22H22F3N
- Structure:
- Chemical Name:
- Nsc529487
- CAS:
- 3310-47-2
- MF:
- C9H13N3O6
- Structure:
- Chemical Name:
- Oxathiolan 5fu-.B.
- CAS:
- 145986-11-4
- MF:
- C8H9FN2O4S
- Structure:
- Chemical Name:
- Decarboxy Enrofloxacin
- CAS:
- 131775-99-0
- MF:
- C18H22FN3O
- Structure:
- Chemical Name:
- Desethanol Dipyridamole
- CAS:
- 1176886-12-6
- MF:
- C22H36N8O3
- Structure:
- Chemical Name:
- 2’’-Desethyl-2’’-vinyl Simvastatin
- CAS:
- 1449248-72-9
- MF:
- C25H36O5
- Chemical Name:
- Posaconazole Impurity 26
- Structure:
- Chemical Name:
- Posaconazole Impurity 48
- CAS:
- 1902954-03-3
- MF:
- C37H42F2N8O5
- Chemical Name:
- Posaconazole Impurity 9
- Chemical Name:
- Roxithromycin Impurity E
- Chemical Name:
- SofosBuvir impurity 48
- Structure:
- Chemical Name:
- SofosBuvir Impurity 54
- CAS:
- 1431932-81-8
- MF:
- C12H17ClNO4P
- Structure:
- Chemical Name:
- Timolol EP Impurity G
- CAS:
- 75202-36-7
- MF:
- C6H9N3O3S
- Structure:
- Chemical Name:
- Tofacitinib Impurity 44
- CAS:
- 2374700-39-5
- MF:
- C13H19N5
- Chemical Name:
- Trelagliptin Impurity 24
- Structure:
- Chemical Name:
- dimethyl 3- isobutylpentanedioate
- CAS:
- 145328-03-6
- MF:
- C11H20O4
- Structure:
- Chemical Name:
- Phenol, 4-chloro-3-[(4-ethoxyphenyl)methyl]-
- CAS:
- 1408077-50-8
- MF:
- C15H15ClO2
- Structure:
- Chemical Name:
- 2-amino-9-((3aS,4S,6S,6aR)-3a,6-dihydroxyhexahydro-1H-cyclopenta[c]furan-4-yl)-1,9-dihydro-6H-purin-6-one
- CAS:
- 1984788-96-6
- MF:
- C12H15N5O4
- Chemical Name:
- Ampicillin Impurity C
- Chemical Name:
- Ampicillin Impurity O
- Chemical Name:
- mixture of PD 312236 and PD 312237
- Structure:
- Chemical Name:
- Axitinib Impurity 27
- CAS:
- 1639137-80-6
- MF:
- C24H20N4O2S
- Structure:
- Chemical Name:
- (4R,5R,6S)-4-nitrobenzyl 6-((R)-1-hydroxyethyl)-4-methyl-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate
- CAS:
- 104873-15-6
- MF:
- C17H18N2O7
- Chemical Name:
- Lesinurad Impurity
- Structure:
- Chemical Name:
- Chrysophanol triglucoside
- CAS:
- 120181-07-9
- MF:
- C33H40O19
- Structure:
- Chemical Name:
- 7H-Pyrazolo[4,3-d]pyrimidin-7-one, 5-(5-chloro-2-ethoxyphenyl)-1,6-dihydro-1-methyl-3-propyl-
- CAS:
- 1829588-57-9
- MF:
- C17H19ClN4O2
- Chemical Name:
- Cefminox sodium impurities Ⅲ
- Structure:
- Chemical Name:
- Canagliflozin Impurity 18
- CAS:
- 1951467-29-0
- MF:
- C24H25FO6S
- Structure:
- Chemical Name:
- Fosaprepitant Impurity 6
- CAS:
- 327623-34-7
- MF:
- C21H19F6NO3
- Structure:
- Chemical Name:
- Ivabradine Impurity 16 HCl
- CAS:
- 304464-98-0
- MF:
- C26H34N2O5
- Chemical Name:
- Moxifloxacin EP Impurity A HCl
- Structure:
- Chemical Name:
- Paroxetine EP Impurity H HCl
- CAS:
- 503834-41-1
- MF:
- C19H23ClFNO
- Structure:
- Chemical Name:
- Solifenacin Related Compound 13
- CAS:
- 1251905-45-9
- MF:
- C17H17NO2
- Structure:
- Chemical Name:
- 1-(3-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboximidamide
- CAS:
- 2101651-50-5
- MF:
- C14H12FN5
- Structure:
- Chemical Name:
- N1-(4-chlorophenyl)-3,12-diimino-N14-phenyl-2,4,11,13-Tetraazatetradecanediimidamide
- CAS:
- 152504-12-6
- MF:
- C22H31ClN10