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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- Structure:
- Chemical Name:
- 9-DIHYDROESTRADIOL
- CAS:
- 791-69-5
- MF:
- C18H22O2
- Structure:
- Chemical Name:
- (2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic Acid (Orlistat Impurity)
- CAS:
- 130676-66-3
- MF:
- C29H55NO6
- Structure:
- Chemical Name:
- (2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic Acid (Orlistat Impurity)
- CAS:
- 130676-66-3
- MF:
- C29H55NO6
- Structure:
- Chemical Name:
- delta(3)-cefotiam
- CAS:
- 142182-63-6
- MF:
- C18H23N9O4S3
- Structure:
- Chemical Name:
- anemonin
- CAS:
- 508-44-1
- MF:
- C10H8O4
- Structure:
- Chemical Name:
- alpha-(chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol
- CAS:
- 62580-79-4
- MF:
- C7H10ClN3O4
- Structure:
- Chemical Name:
- 7-(deoxyadenosin-N(6)-yl)aristolactam I
- CAS:
- 127191-86-0
- MF:
- C27H22N6O7
- Structure:
- Chemical Name:
- 4'-hydroxyflurbiprofen
- CAS:
- 52807-12-2
- MF:
- C15H13FO3
- Structure:
- Chemical Name:
- D-biotin-d-sulfoxide
- CAS:
- 10406-89-0
- MF:
- C10H16N2O4S
- Structure:
- Chemical Name:
- 3,4-dihydroxyphenylpyruvic acid
- CAS:
- 4228-66-4
- MF:
- C9H8O5
- Chemical Name:
- Imimidistine impurity E
- Structure:
- Chemical Name:
- 4-hydroxypenicillin V
- CAS:
- 20880-67-5
- MF:
- C16H18N2O6S
- Structure:
- Chemical Name:
- BENAZEPRILAT
- CAS:
- 86541-78-8
- MF:
- C22H24N2O5
- Structure:
- Chemical Name:
- 9-Methylene-9H-fluorene
- CAS:
- 4425-82-5
- MF:
- C14H10
- Structure:
- Chemical Name:
- 2-PIPERIDIN-4-YL-1H-BENZOIMIDAZOLE
- CAS:
- 38385-95-4
- MF:
- C12H15N3
- Chemical Name:
- Rocuronium Bromide Impurity 19 、21、22
- Chemical Name:
- Flucloxacillin impurity D
- Chemical Name:
- Ritonavir EP Impurity STU
- Structure:
- Chemical Name:
- 4-BROMO-1-(TOLUENE-4-SULFONYL)-1,2,3,4-TETRAHYDROBENZO[B]AZEPIN-5-ONE
- CAS:
- 29489-04-1
- MF:
- C17H16BrNO3S
- Chemical Name:
- Lincomycin sulfoxide Impurity 4
- Chemical Name:
- Sulpiride Impurity 3
- Chemical Name:
- Doxofylline iMpurity F
- Chemical Name:
- He pulls non-EP impurities D
- Structure:
- Chemical Name:
- R-(-)-O-DESMETHYLVENLAFAXINE
- CAS:
- 142761-11-3
- MF:
- C16H25NO2
- Structure:
- Chemical Name:
- MILRINONE RELATED COMPOUND A (50 MG) (1,6-DIHYDRO-2-METHYL-6-OXO(3,4'-BIPYRIDINE)-5-CAR-BOXAMIDE)
- CAS:
- 80047-24-1
- MF:
- C12H11N3O2
- Structure:
- Chemical Name:
- 3-Anilino-2-(3,4,5-triMethoxybenzyl)acrylonitrile, (Mixture of cis/trans isoMers)
- CAS:
- 30078-48-9
- MF:
- C19H20N2O3
- Structure:
- Chemical Name:
- Anastrozole EP Impurity I
- CAS:
- 120511-91-3
- MF:
- C15H17ClN2
- Structure:
- Chemical Name:
- (2R,5S)-5-(3,4-Dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester
- CAS:
- 389128-28-3
- MF:
- C18H26N2O5S
- Chemical Name:
- Everolimus impurity F
- Chemical Name:
- Letermovir Impurity 1
- Chemical Name:
- Roxadustat Impurity 16
- Chemical Name:
- Perospirone Impurity 19
- Chemical Name:
- Dolutegravir Impurity 14(Sodium Salt)
- Chemical Name:
- Fondaparinux sodium impurity 5
- Chemical Name:
- Fondaparinux sodium impurity 20
- Chemical Name:
- Piperacillin Impurity R
- Chemical Name:
- Lasmiditan Impurity 6
- Chemical Name:
- 1-methylpyrrolidin-3-yl 2-(4-chlorophenyl)-2-cyclopentyl- 2-hydroxyacetate hydrochloride
- Chemical Name:
- Lasmiditan Impurity 8
- Structure:
- Chemical Name:
- 1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl) piperazine 1-oxide dihydrate
- CAS:
- 2760465-02-7
- MF:
- C17H22N4O2S
- Structure:
- Chemical Name:
- Ethacridine Impurity 10
- CAS:
- 20304-71-6
- MF:
- C21H16N2O4
- Structure:
- Chemical Name:
- (S)-N-(1-Azabicyclo[2.2.2]oct-3-yl)-5,6,7,8-tetrahydro-1-naphthalenecarboxamide
- CAS:
- 135729-78-1
- MF:
- C18H24N2O
- Chemical Name:
- 2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid
- Chemical Name:
- Olodaterol Impurity 31
- Structure:
- Chemical Name:
- (S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
- CAS:
- 192726-05-9
- MF:
- C27H38N4O3
- Structure:
- Chemical Name:
- 2-Hydrazinoadenosine
- CAS:
- 15763-11-8
- MF:
- C10H15N7O4
- Structure:
- Chemical Name:
- N-Desmethyl Clarithromycin
- CAS:
- 101666-68-6
- MF:
- C37H67NO13
- Chemical Name:
- Oseltamivir Impurity 126
- Chemical Name:
- Oseltamivir Impurity 126
- Structure:
- Chemical Name:
- 2H-1,4-Benzoxazin-3(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-hydroxyphenyl)-1,1-dimethylethyl]amino]ethyl]-, hydrochloride (1:1)
- CAS:
- 936490-85-6
- MF:
- C20H25ClN2O5
- Structure:
- Chemical Name:
- Desacetylvinblastine hydrazide
- CAS:
- 55383-37-4
- MF:
- C43H56N6O7
- Structure:
- Chemical Name:
- 4-hydroxypyrrolidin-2-one
- CAS:
- 96820-00-7
- MF:
- C4H7NO2
- Structure:
- Chemical Name:
- glycopyrronium bromide
- CAS:
- 475468-09-8
- MF:
- C19H28NO3.Br
- Structure:
- Chemical Name:
- protosappanin A
- CAS:
- 102036-28-2
- MF:
- C15H12O5
- Chemical Name:
- Apremilast Impurity TNB
- Chemical Name:
- Atracurium Impurity N
- Chemical Name:
- Avibactam Impurity X
- Chemical Name:
- Cefazolin Impurity L
- Chemical Name:
- Ceftazidime hetero trans oxidation Impurity
- Chemical Name:
- Regorafenib Impurity 17
- Chemical Name:
- Ropivacaine Impurity 45
- CAS:
- 2726971-51-1
- Structure:
- Chemical Name:
- Sildenafil Impurity 17
- MF:
- C22H30N6O4S
- Chemical Name:
- Sugammadex sodium Org199074-1 Impurity
- Chemical Name:
- Sugammadex sodium Org238832-1 Impurity
- Chemical Name:
- Afatinib impurity 33
- Structure:
- Chemical Name:
- Avibactam Impurity 38
- CAS:
- 2241730-86-7
- MF:
- C20H29BrN2O5
- Structure:
- Chemical Name:
- Butyphthalide impurity 27
- CAS:
- 33704-16-4
- MF:
- C12H12O5
- Chemical Name:
- Butyphthalide impurity 35
- Chemical Name:
- Canagliflozin Impurity 31
- Structure:
- Chemical Name:
- Celecoxib Impurity 21
- CAS:
- 2055787-31-8
- MF:
- C17H12F3N3O3S
- Chemical Name:
- Emtricitabine Impurity CFTU2
- Chemical Name:
- Febuxostat Impurity 88
- Chemical Name:
- Ceftriaxone Sodium impurity 4
- Chemical Name:
- Sugammadex sodium Hepta-Iodine Impurity
- Chemical Name:
- Abitrone project impurity
- Structure:
- Chemical Name:
- 105981-34-8
- CAS:
- 105981-34-8
- MF:
- C15H22N4S
- Structure:
- Chemical Name:
- 1364671-52-2
- CAS:
- 1364671-52-2
- MF:
- C19H19ClN6O3S
- Structure:
- Chemical Name:
- 1627504-43-1
- CAS:
- 1627504-43-1
- MF:
- C14H14ClN7
- Chemical Name:
- Pramipexole Impurity Q
- Structure:
- Chemical Name:
- Aprepitant Impurity 42
- CAS:
- 172678-47-6
- MF:
- C20H18F7NO2
- Structure:
- Chemical Name:
- Efinaconazole Related Impurity 13
- CAS:
- 2055912-03-1
- MF:
- C24H32FN5O
- Chemical Name:
- DexMedetoMidine IMpurity 17
- Structure:
- Chemical Name:
- Sofosbuvir IMpurity 21
- CAS:
- 2138483-01-7
- MF:
- C17H17FN2O6
- Chemical Name:
- Moxifloxacin Impurity 1
- Chemical Name:
- Moxifloxacin Impurity 22
- Chemical Name:
- Linagliptin Impurity F
- Chemical Name:
- Trelagliptin Impurity 4
- Chemical Name:
- Fudosteine Impurity 1
- Structure:
- Chemical Name:
- Sugammadex Impurity 17
- CAS:
- 2414905-36-3
- MF:
- C82H120NaO48PS7
- Chemical Name:
- Apixaban Impurity 28
- CAS:
- 2208275-54-9
- Structure:
- Chemical Name:
- Fluvastatin EP Impurity E
- MF:
- C24H26FNO4
- Chemical Name:
- Oseltamivir Impurity 24
- Structure:
- Chemical Name:
- (3S,3'S,4R,4'R)-diphenyl 3,3'-(oxybis(methylene))bis(4-(4- fluorophenyl)piperidine-1-carboxylate)
- MF:
- C38H38F2N2O5
- Chemical Name:
- Nettopitan impurity
- Structure:
- Chemical Name:
- Afatinib Impurity 74
- CAS:
- 1259015-90-1
- MF:
- C7H13NO2
- Chemical Name:
- Afatinib Impurity 78
- Structure:
- Chemical Name:
- Cabozantinib Impurity 47
- CAS:
- 113136-79-1
- MF:
- C11H10ClNO3
- Chemical Name:
- Landiolol impurity Q
- Chemical Name:
- Tenofovir Impurity 72
- Structure:
- Chemical Name:
- Medetomidine Impurity 52
- CAS:
- 128366-51-8
- MF:
- C13H14N2O2