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 CAS MF
CARBOFURAN-3-HYDROXY CARBOFURAN-3-HYDROXY 16655-82-6 C12H15NO4
ALDICARB-SULFONE ALDICARB-SULFONE 1646-88-4 C7H14N2O4S
DIHYDROERGOCRISTINE MESYLATE DIHYDROERGOCRISTINE MESYLATE 24730-10-7 C36H45N5O8S
AFLATOXIN M1 AFLATOXIN M1 6795-23-9 C17H12O7
EPN EPN 2104-64-5 C14H14NO4PS
2,3,4,5-TETRACHLOROPHENOL 2,3,4,5-TETRACHLOROPHENOL 4901-51-3 C6H2Cl4O
Terbacil Terbacil 5902-51-2 C9H13ClN2O2
MEPENZOLATE BROMIDE MEPENZOLATE BROMIDE 76-90-4 C21H26BrNO3
Pyributicarb Pyributicarb 88678-67-5 C18H22N2O2S
N-DESMETHYLCLOZAPINE N-DESMETHYLCLOZAPINE 6104-71-8 C17H17ClN4
PENTACHLOROANISOLE PENTACHLOROANISOLE 1825-21-4 C7H3Cl5O
Soybean Flour Soybean Flour 68513-95-1
BROMOPRIDE BROMOPRIDE 4093-35-0 C14H22BrN3O2
Tris(2,3-dibromopropyl)phosphate Tris(2,3-dibromopropyl)phosphate 126-72-7 C9H15Br6O4P
Chlordecone Chlordecone 143-50-0 C10Cl10O
3,4,5-TRICHLOROPHENOL 3,4,5-TRICHLOROPHENOL 609-19-8 C6H3Cl3O
4-CARBOXY-2,2,6,6-TETRAMETHYLPIPERIDINE 1-OXYL 4-CARBOXY-2,2,6,6-TETRAMETHYLPIPERIDINE 1-OXYL 37149-18-1 C10H18NO3*
QUINMERAC QUINMERAC 90717-03-6 C11H8ClNO2
6-METHYLCHRYSENE 6-METHYLCHRYSENE 1705-85-7 C19H14
METHYSTICIN METHYSTICIN 495-85-2 C15H14O5
CAPECITABINE-D11 CAPECITABINE-D11 1132662-08-8 C15H13D11FN3O6
Abacavir Abacavir 141271-12-7 C10H14ClN5O
Canagliflozin Impurity 42 Canagliflozin Impurity 42
Maleic Acid Maleic Acid 2170020-79-6 C21H20FN3O6S
Ozagrel Impurity 21 Ozagrel Impurity 21 883942-98-1 C23H20N2O4
Terbutaline  Impurity Terbutaline Impurity 1226543-90-3 C22H20O4
lidocaine impurity lidocaine impurity 1374010-02-2 C30H36N4O3
Desloratadine Impurity 7 Desloratadine Impurity 7
Esomeprazole Impurity 28 Esomeprazole Impurity 28
ethyl 2-(3-carbamoyl-4-isobutoxyphenyl)-4-methylthiazole-5- carboxylate ethyl 2-(3-carbamoyl-4-isobutoxyphenyl)-4-methylthiazole-5- carboxylate 1346238-15-0 C18H22N2O4S
Ropivacaine impurity Ropivacaine impurity 1786518-57-7 C13H16N2O3
Mono Oxidation Sugammadex(Org199425-1) Mono Oxidation Sugammadex(Org199425-1) 2412953-14-9 C72H113NaO49S8
1-Cyanocyclohexaneacetic acid 1-Cyanocyclohexaneacetic acid 133481-09-1 C9H13NO2
2,4,6-TRI-TERT-BUTYLNITROSOBENZENE 2,4,6-TRI-TERT-BUTYLNITROSOBENZENE 24973-59-9 C18H29NO
2,4-DIAMINO-6-DIMETHYLAMINO-1,3,5-TRIAZINE 2,4-DIAMINO-6-DIMETHYLAMINO-1,3,5-TRIAZINE 1985-46-2 C5H10N6
2,4,5-TRICHLOROTOLUENE 2,4,5-TRICHLOROTOLUENE 6639-30-1 C7H5Cl3
NEOERIOCITRIN NEOERIOCITRIN 13241-32-2 C27H32O15
Triflumizole Triflumizole 99387-89-0 C15H15ClF3N3O
NEBURON NEBURON 555-37-3 C12H16Cl2N2O
2,4-DB METHYL ESTER 2,4-DB METHYL ESTER 18625-12-2 C11H12Cl2O3
CAPTOPRIL DISULFIDE CAPTOPRIL DISULFIDE 64806-05-9 C18H28N2O6S2
1-PHENYLPENTADECANE 1-PHENYLPENTADECANE 2131-18-2 C21H36
2-(Ethylamino)propiophenone hydrochloride 2-(Ethylamino)propiophenone hydrochloride 51553-17-4 C11H16ClNO
IOXYNIL OCTANOATE IOXYNIL OCTANOATE 3861-47-0 C15H17I2NO2
2-BENZYL-1,2,3,6,7,11B-HEXAHYDRO-4H-PYRAZION[2,1-A] ISOQUINOLINE-4-ONE 2-BENZYL-1,2,3,6,7,11B-HEXAHYDRO-4H-PYRAZION[2,1-A] ISOQUINOLINE-4-ONE 54761-87-4 C19H18N2O2
TETRACONAZOLE TETRACONAZOLE 112281-77-3 C13H11Cl2F4N3O
PENTACHLOROTHIOANISOLE PENTACHLOROTHIOANISOLE 1825-19-0 C7H3Cl5S
CHLORFENAC CHLORFENAC 85-34-7 C8H5Cl3O2
M-CYMENE M-CYMENE 535-77-3 C10H14
MICROCYSTIN-LR MICROCYSTIN-LR 101043-37-2 C49H74N10O12
FLONICAMID FLONICAMID 158062-67-0 C9H6F3N3O
OXELADIN CITRATE OXELADIN CITRATE 52432-72-1 C20H33NO3.C6H8O7
2,4,6-TRIS(HEPTAFLUOROPROPYL)-1,3,5-TRIAZINE 2,4,6-TRIS(HEPTAFLUOROPROPYL)-1,3,5-TRIAZINE 915-76-4 C12F21N3
2-Diphenylmethylpiperidine hydrochloride 2-Diphenylmethylpiperidine hydrochloride 5807-81-8 C18H22ClN
Bendamustine Related Impurity 2 Bendamustine Related Impurity 2
Bendamustine Related Impurity 7 Bendamustine Related Impurity 7
Bortezomib Impurity 25 Bortezomib Impurity 25
Bortezomib Impurity 40 Bortezomib Impurity 40
Edoxaban Impurity 28 (1R,2R,4R) Edoxaban Impurity 28 (1R,2R,4R) 1255529-38-4 C21H30ClN5O5
Linagliptin Impurity 31 Linagliptin Impurity 31
Olopatadine Impurity 1 Olopatadine Impurity 1 66801-40-9 C15H10O4
Paroxetine Impurity 12 Paroxetine Impurity 12
Rivaroxaban Impurity 69 DiHCl Rivaroxaban Impurity 69 DiHCl
Sitafloxacin Impurity 5 Sitafloxacin Impurity 5 1630983-99-1 C15H12ClF4NO3
Ticagrelor Related Compound 92 Ticagrelor Related Compound 92
Valsartan Impurity 10 Valsartan Impurity 10 1314799-74-0 C23H29N5O
Vonoprazan Impurity 23 Vonoprazan Impurity 23
Adefovir Impurity 1 Adefovir Impurity 1
Bendamustine Impurity G Bendamustine Impurity G
Blonanserin Impurity K Blonanserin Impurity K
Brexpiprazole Impurity F Brexpiprazole Impurity F
Cefazolin USP Impurity D Cefazolin USP Impurity D
Cefuroxime Impurity 9 Cefuroxime Impurity 9 2165460-37-5 C8H10N2O4S
Everolimus Impurity E Everolimus Impurity E
Peramivir Impurity 3 Peramivir Impurity 3
Peramivir Impurity 8 Peramivir Impurity 8
Pitavastatin Impurity 13 Pitavastatin Impurity 13
Pramipexole Impurity R Pramipexole Impurity R
Tadalafil Impuirty 21 Tadalafil Impuirty 21
Moxifloxacin Impurity 40 Moxifloxacin Impurity 40 121577-35-3 C15H16F3NO4
sodium 2-(((3,4-dimethoxypyridin-2-yl)methyl)thio)-5- hydroxy-4-sulfonatobenzo[d]imidazol-1-ide sodium 2-(((3,4-dimethoxypyridin-2-yl)methyl)thio)-5- hydroxy-4-sulfonatobenzo[d]imidazol-1-ide C15H13N3Na2O6S2
Dexmedetomidine-007 Dexmedetomidine-007 2240179-63-7 C13H16N2
2-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide 2-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide 2304623-37-6 C16H14N2O3S
Miconazole EP Impurity F Miconazole EP Impurity F 47447-55-2 C18H14Cl4N2O
Raltegravir USP RC E Raltegravir USP RC E 1193687-87-4 C20H22N6O5
Vigabatrin EP Impurity F Vigabatrin EP Impurity F 794466-81-2 C12H20N2O3
Dehydronitrosonisoldipine Dehydronitrosonisoldipine 87375-91-5 C20H22N2O5
Brexpiprazole Impurity 49 Brexpiprazole Impurity 49 1700655-67-9 C13H14N2O2S
Etoricoxib Impurity 38 Etoricoxib Impurity 38 887479-63-2 C13H17NO2S
Pemetrexed Impurity 19 Pemetrexed Impurity 19 1644286-36-1 C20H21N5O8
Empagliflozin Impurity 31 Empagliflozin Impurity 31
Iguratimod Iguratimod 123663-50-3 C18H16N2O6S
1,4-bis(4-((1,4,8,11-tetraazacyclotetradecan-4,8,11-trifluoroacetyl- 1-yl)methyl)benzyl)-8,11-difluoroacetyl-1,4,8,11-tetraazacyclotetra decane 1,4-bis(4-((1,4,8,11-tetraazacyclotetradecan-4,8,11-trifluoroacetyl- 1-yl)methyl)benzyl)-8,11-difluoroacetyl-1,4,8,11-tetraazacyclotetra decane
Imidafenacin Related Compound 10 Imidafenacin Related Compound 10 212756-27-9 C21H23N3O
Aprepitant Aprepitant 1242175-36-5 C20H18F7NO2
Idebenone Impurity 5 Idebenone Impurity 5 88543-33-3 C18H28O5
Entacapone Impurity 4 Entacapone Impurity 4 1202160-40-4 C11H8N2O6
L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]tridecyl ester L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]tridecyl ester 1119226-56-0 C30H55NO5
Itraconazole Impurity 17 Itraconazole Impurity 17 854372-78-4 C14H15Cl2N3O5S
sodium (41S,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12, 13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5] naphthyridine-12-carboxylate sodium (41S,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12, 13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5] naphthyridine-12-carboxylate 53448-45-6 C20H24N2O3
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